188 results on '"Kushida CA"'
Search Results
2. 0527 ROLE OF SPOUSE IN CPAP ADHERENCE
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Batool-Anwar, S, primary, Baldwin, CM, additional, Fass, S, additional, Goodwin, JL, additional, Kushida, CA, additional, Nichols, D, additional, and Quan, SF, additional
- Published
- 2017
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3. BACKGROUND: Asthma and Allergic Rhinitis (AR) are two chronic inflammatory diseases that are often concomitant. The Control of Allergic Rhinitis and Asthma Test (CARAT) was developed to evaluate the control of these diseases from the patients' perspective. Its performance in asthma patients without AR has not been previously studied. AIM: To test the hypothesis that CARAT can be used to assess asthma control in patients with asthma and without AR. METHODS: A cross-sectional study was conducted in 3 primary healthcare centres in Northern Portugal. Adult patients identified in the Electronic Patient Record with a diagnosis of asthma were invited to participate. CARAT was used to assess asthma control and Asthma Control Test (ACT) as a comparator. The associations between asthma patients without AR (AsAR) and with AR (AwAR) were analyzed with Spearman correlation. Additionally, Receiver Operating Characteristic (ROC) curve analysis, summarized by Area Under the Curve (AUC), was used to assess performance of CARAT for screening asthma that was not well-controlled. RESULTS: A total of 103 asthma patients completed the study, 64 (62%) had AwAR and in 87 (85%) asthma was not well-controlled. We observed a strong correlation between CARAT and ACT scores (r=0.734) in all asthma patients and in both groups: AsAR (r=0.737) and AwAR (r=0.843). ROC curve demonstrated CARAT as having a good discriminative power for both AsAR and AwAR groups (AUC=0.894 and 0.946, respectively). CONCLUSION: These initial results suggest that CARAT has a good discriminative performance, similar to other asthma control assessment tools, for asthma patients with and without AR
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Riaz, M, Certal, V, Nigam, G, Abdullatif, J, Zaghi, S, Kushida, CA, and Camacho, M
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Positive-Pressure Respiration ,Sleep Apnea, Obstructive ,Apneia do Sono Tipo Obstrutiva ,Respiração com Pressão Positiva - Abstract
Objective. To quantify the effectiveness of nasal expiratory positive airway pressure (nasal EPAP) devices or Provent as treatment for obstructive sleep apnea (OSA). Methods. PubMed and six other databases were searched through November 15, 2015, without language limitations. Results. Eighteen studies (920 patients) were included. Pre- and post-nasal EPAP means ± standard deviations (M ± SD) for apnea-hypopnea index (AHI) in 345 patients decreased from 27.32 ± 22.24 to 12.78 ± 16.89 events/hr (relative reduction = 53.2%). Random effects modeling mean difference (MD) was -14.78 events/hr [95% CI -19.12, -10.45], p value < 0.00001. Oxygen desaturation index (ODI) in 247 patients decreased from 21.2 ± 19.3 to 12.4 ± 14.1 events/hr (relative reduction = 41.5%, p value < 0.00001). Lowest oxygen saturation (LSAT) M ± SD improved in 146 patients from 83.2 ± 6.8% to 86.2 ± 11.1%, MD 3 oxygen saturation points [95% CI 0.57, 5.63]. Epworth Sleepiness Scale (ESS) M ± SD improved (359 patients) from 9.9 ± 5.3 to 7.4 ± 5.0, MD -2.5 [95% CI -3.2, -1.8], p value < 0.0001. Conclusion. Nasal EPAP (Provent) reduced AHI by 53.2%, ODI by 41.5% and improved LSAT by 3 oxygen saturation points. Generally, there were no clear characteristics (demographic factors, medical history, and/or physical exam finding) that predicted favorable response to these devices. However, limited evidence suggests that high nasal resistance could be associated with treatment failure. Additional studies are needed to identify demographic and polysomnographic characteristics that would predict therapeutic success with nasal EPAP (Provent).
- Published
- 2015
4. Central sleep apnea due to a medical condition not Cheyne Stokes
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Kushida, CA, Kehlmann, GB, Eckert, DJ, Kushida, CA, Kehlmann, GB, and Eckert, DJ
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Central sleep apnea is characterized by insufficient drive to breathe during sleep and is associated with major comorbidity. There are many forms of central sleep apnea including the classic Cheyne–Stokes breathing pattern, which is relatively common in patients with advanced heart failure. This article focuses on the other forms of central sleep apnea that may occur in conjunction with various medical conditions including brain stem tumors/abnormalities, chronic pain/cancer/drug abuse, congenital central hypoventilation syndrome, insomnia, neuromuscular conditions, obesity hypoventilation syndrome, periodic leg movement disorder, renal failure, and stroke.
- Published
- 2013
5. History - Features, Factors, and Characteristics of Parasomnias
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Kushida, CA, Riva, M, Tremolizzo, L, Riva, MA, Kushida, CA, Riva, M, Tremolizzo, L, and Riva, MA
- Abstract
Since antiquity, the mystery around sleep and its disorders, particularly parasomnias, has fostered superstitions, myths, and tales. In modern times, physicians attempted to explain these phenomena as neuropsychiatric and organic diseases. The definitive acknowledgment of parasomnias as organic disorders occurred only during the twentieth century when sleep medicine became a scientific discipline. Recently, the development of the modern polysomnography has allowed improved but incomplete understanding regarding the pathophysiology of the parasomnias.
- Published
- 2013
6. P.047 Effect of lemborexant on sleep architecture in subjects with comorbid insomnia and mild obstructive sleep apnea from a phase 3 trial
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Kushida, CA, Zammit, GK, Cheng, JY, Kumar, D, and Moline, M
- Abstract
Background: Lemborexant (LEM), a dual-orexin-receptor-antagonist approved to treat adults with insomnia, increases total sleep time (TST) and rapid eye movement (REM) sleep. Patients with obstructive sleep apnea (OSA) or co-morbid insomnia and OSA (COMISA) report sleeping difficulties and reduced REM, therefore sleep architecture was analyzed during LEM treatment. Methods: Study E2006-G000-304 (NCT02783729) was a 1-month, randomized, double-blind, placebo (PBO)- and active-comparator zolpidem-ER 6.25mg (ZOL)-controlled study in adults ≥55y with insomnia disorder. Subjects received PBO, LEM 5mg (LEM5), 10mg (LEM10), or ZOL. Least-square-mean duration of each sleep stage (minutes) was compared from pooled data on Nights (NT)1/2 and NT29/30 for mild OSA subjects (apnea hypopnea index ≥5 to <15 events/h). Treatment-emergent adverse events (TEAEs) were recorded. Results: Of 409 subjects with mild OSA (LEM5=114/LEM10=105/ZOL=112/PBO=78) change from baseline (CFB) in TST and REM sleep was significantly larger with both LEM doses versus ZOL/PBO on both nights. CFB for total nonREM sleep was significantly higher (P<0.0001) with both LEM doses versus PBO on both nights. LEM5 showed significantly higher (P<0.05) nonREM sleep versus ZOL at NT29/30. Most TEAEs were mild/moderate. Conclusions: LEM significantly increased TST, REM, and nonREM sleep versus PBO in subjects with insomnia and mild OSA. Data support LEM treatment in the COMISA population.
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- 2023
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7. PNL21 FUNCTIONAL LIMITATIONS, MENTAL HEALTH, AND RESOURCE USE ASSOCIATED WITH THE HEALTH-RELATED QUALITY OF LIFE OF PATIENTS WITH RESTLESS LEGS SYNDROME
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Martin, MC, primary, Nikam, P, additional, Blaisdell, B, additional, Kushida, CA, additional, Ferini Strambi, L, additional, and Ware, J, additional
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- 2005
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8. PNL20 RESTLESS LEGS SYNDROME PLACES A SUBSTANTIAL BURDEN ON THE HEALTH-RELATED QUALITY OF LIFE OF US AND EUROPEAN PATIENTS
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Martin, MC, primary, Nikam, P, additional, Blaisdell, B, additional, Kushida, CA, additional, Ferini Strambi, L, additional, and Ware, J, additional
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- 2005
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9. Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS.
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Kushida CA, Becker PM, Ellenbogen AL, Canafax DM, Barrett RW, and XP052 Study Group
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- 2009
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10. A randomised, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome.
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Kushida CA, Walters AS, Becker P, Thein SG, Perkins AT, Roth T, Canafax D, and Barrett RW
- Published
- 2009
11. The expression of m1-m3 muscarinic receptor mRNAs in rat brain following REM sleep deprivation
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Kushida Ca, Rebecca K. Zoltoski, and Gillin Jc
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medicine.medical_specialty ,Rapid eye movement sleep ,Sleep, REM ,Biology ,Rats, Sprague-Dawley ,Internal medicine ,Muscarinic acetylcholine receptor ,medicine ,Animals ,RNA, Messenger ,In Situ Hybridization ,musculoskeletal, neural, and ocular physiology ,General Neuroscience ,Pontine nuclei ,Brain ,Muscarinic acetylcholine receptor M3 ,Muscarinic acetylcholine receptor M2 ,Muscarinic acetylcholine receptor M1 ,Receptors, Muscarinic ,Sleep in non-human animals ,Rats ,Stria terminalis ,Endocrinology ,Autoradiography ,Sleep Deprivation ,psychological phenomena and processes - Abstract
We used in situ hybridization histochemistry to study the effects of REM sleep deprivation on m1-m3 muscarinic receptor mRNA expression in the rat brain. REM sleep deprivation for 72 h did not affect m1 receptor mRNA expression. However, we found significantly increased m3 receptor mRNA expression in the pontine nuclei and nucleus accumbens-bed nucleus of the stria terminalis region of REM sleep-deprived rats compared with controls. Paradoxically, we found significantly decreased m2 receptor mRNA expression in the pontine nuclei of REM sleep-derived rats vs controls. The present findings implicate these structures in the cholinergic effector pathways of REM sleep, although the type and magnitude of the effects of these structures on REM sleep may vary with different receptor subtypes.
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- 1995
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12. Efficacy and safety of pramipexole in restless legs syndrome.
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Winkelman JW, Sethi KD, Kushida CA, Becker PM, Koester J, Cappola JJ, Reess J, Winkelman, J W, Sethi, K D, Kushida, C A, Becker, P M, Koester, J, Cappola, J J, and Reess, J
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- 2006
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13. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders: an American Academy of Sleep Medicine report.
- Author
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Kushida CA, Littner MR, Hirshkowitz M, Morgenthaler TI, Alessi CA, Bailey D, Boehlecke B, Brown TM, Coleman J Jr., Friedman L, Kapen S, Kapur VK, Kramer M, Lee-Chiong T, Owens J, Pancer JP, Swick TJ, and Wise MS
- Published
- 2006
14. Practice parameters for the treatment of snoring and Obstructive Sleep Apnea with oral appliances: an update for 2005.
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Kushida CA, Morgenthaler TI, Littner MR, Alessi CA, Bailey D, Coleman J Jr., Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Owens J, and Pancer JP
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- 2006
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15. Practice parameters for the indications for polysomnography and related procedures: an update for 2005.
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Kushida CA, Littner MR, Morgenthaler T, Alessi CA, Bailey D, Coleman J Jr., Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Loube DL, Owens J, Pancer JP, and Wise M
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- 2005
16. Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome.
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Allen R, Becker PM, Bogan R, Schmidt M, Kushida CA, Fry JM, Poceta JS, and Winslow D
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- 2004
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17. Anterior cervical spine fusion and sleep disordered breathing.
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Guilleminault C, Li KK, Philip P, Kushida CA, Guilleminault, Christian, Li, Kasey K, Philip, Pierre, and Kushida, Clete A
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- 2003
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18. Book reviews.
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Ginsberg DA, Figlin RA, Lester SC, and Kushida CA
- Published
- 2008
19. History – Features, Factors, and Characteristics of Parasomnias
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Lucio Tremolizzo, Michele Augusto Riva, Kushida, CA, Riva, M, and Tremolizzo, L
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History ,medicine.medical_specialty ,medicine.diagnostic_test ,Sleep terror ,Organic disorders ,Polysomnography ,Mythology ,medicine.disease ,Sleep medicine ,Nightmare ,MED/02 - STORIA DELLA MEDICINA ,medicine ,medicine.symptom ,Psychiatry ,Psychology ,Sleep paralysis ,Neuroscience - Abstract
Since antiquity, the mystery around sleep and its disorders, particularly parasomnias, has fostered superstitions, myths, and tales. In modern times, physicians attempted to explain these phenomena as neuropsychiatric and organic diseases. The definitive acknowledgment of parasomnias as organic disorders occurred only during the twentieth century when sleep medicine became a scientific discipline. Recently, the development of the modern polysomnography has allowed improved but incomplete understanding regarding the pathophysiology of the parasomnias.
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- 2013
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20. Arousal threshold modifies the effect of CPAP on executive function among individuals with obstructive sleep apnea.
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Zinchuk AV, Kushida CA, Walker A, Wellman A, Azarbarzin A, Alex RM, Varga AW, Sands SA, and Yaggi HK
- Abstract
Arousal Threshold Modifies the Effect of CPAP on Executive Function Among Individuals with Obstructive Sleep Apnea., Background: Obstructive Sleep Apnea (OSA) is associated with neurocognitive dysfunction. However, randomized trials evaluating the effects of continuous positive airway pressure (CPAP) on neurocognition in those without dementia do not show a benefit. We thus aimed to assess whether arousal threshold (ArTH) modifies the effect of CPAP on neurocognitive function., Methods: We performed a secondary analysis of a randomized, sham-controlled trial, Apnea Positive Pressure Long-term Efficacy Study. ArTH was estimated from polysomnography using a translatable method (Sands et al ., SLEEP 2018). Neurocognitive outcomes included the Sustained Working Memory Test-Overall-Mid-Day score (SWMT-OMD, executive function, primary outcome), with the Pathfinder Number Test - total time (attention) and Buschke Selective Reminding Test - sum recall (learning and memory) as secondary outcomes. Generalized linear modeling assessed whether the effect of CPAP was modified by baseline ArTH (treatment-by-ArTH interaction). 833 participants with OSA, [apnea-hypopnea index (AHI) ≥10 events/h], available ArTH, and outcomes were analyzed (CPAP n=437, Sham n=396)., Results: For executive function, the effect of CPAP treatment was modified by ArTH (p-interaction=0.042). Specifically, for every 1 sd increase in ArTH, the SWMT-OMD score improved by 0.10 95% CI (0.01, 0.18) in active compared to sham CPAP at 6 months; At ArTH 1 sd above the mean SWMT-OMD improvements were nearly three times that in those with average ArTH (0.139 [0.018, 0.261] versus 0.053 [-0.034, 0.140] respectively. No effect modification was observed for attention (p=0.311) or learning and memory (p=0.744)., Conclusion: In OSA, a higher ArTH is associated with greater improvements in executive function following CPAP therapy., (Copyright ©The authors 2024. For reproduction rights and permissions contact permissions@ersnet.org.)
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- 2024
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21. Morphometric measures and desaturations: Proposal for an index with improved accuracy for obstructive sleep apnea screening.
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Galtieri R, Salles C, Kushida CA, Meira E Cruz M, and Souza-Machado A
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- Humans, Female, Male, Middle Aged, Adult, Oxygen Saturation physiology, Mass Screening methods, Neck anatomy & histology, Sleep Apnea, Obstructive diagnosis, Polysomnography, Sensitivity and Specificity, Body Mass Index
- Abstract
Study Objective: To evaluate the sensitivity and specificity of the combined Kushida morphometric model (KMM) and the oxygen desaturation index (ODI) for screening individuals with obstructive sleep apnea., Methods: Diagnostic test study with adults >18 years, both sexes, polysomnography, body mass index, neck circumference and intraoral measurements., Results: 144 patients were invited; of these, 75 met the exclusion criteria. 55 individuals presented AHI ≥5 ev/h and 14, an AHI <5 ev/h. Three AHI cut-off points were evaluated: AHI ≥5, ≥15, ≥30 ev/h. When adopting the cut-off point of AHI ≥5 ev/h, the KMM showed sensitivity (SE) = 60.0 %, specificity (SP) = 71.4 % and 95 % confidence interval of the area under the curve (95 % CI of AUC) = 0.655; the combination of KMM and ODI (KMM + ODI) revealed SE = 73.0 %, SP = 71.4 % (95 % CI of AUC = 0.779) and the ODI showed SE = 76.4 % and SP = 92.9 % (95 % CI of AUC = 0.815). At the cut-off point of AHI ≥15 ev/h, the KMM presented SE = 64.1 %, SP = 76.7 % (95 % CI of AUC = 0.735); the KMM + ODI showed SE = 82.1 %, SP = 83.3 % (95 % CI of AUC = 0.895); and the ODI presented SE = 76.9 %, SP = 100.0 % (95 % CI of AUC = 0.903). For the cut-off point of AHI ≥30 ev/h, the KMM showed SE = 56.0 %, SP = 77.2 % (95 % CI of AUC = 0.722); the KMM + ODI revealed SE = 92.0 %, SP = 79.5 % (95 % CI of AUC = 0.926); and the ODI showed SE = 92.0 %, SP = 90.9 % (95 % CI of AUC = 0.941)., Conclusion: The combination of oxygen desaturation index and Kushida morphometric model improved the sensitivity and specificity of this model regardless of obstructive sleep apnea severity suggesting greater effectiveness in risk prediction., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Adelmir Souza-Machado reports financial support was provided by National Council for Scientific and Technological Development, Research Support Foundation of the State of Bahia. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)
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- 2024
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22. Sleep macro-architecture in patients with Parkinson's disease does not change during the first night of neurostimulation in a pilot study.
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Das R, Gliske SV, West LC, Summers MO, Tang S, Hirt L, Maroni D, Halpern CH, Thompson JA, Kushida CA, and Abosch A
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- Aged, Female, Humans, Male, Middle Aged, Pilot Projects, Sleep physiology, Sleep Wake Disorders diagnosis, Sleep Wake Disorders etiology, Sleep Wake Disorders physiopathology, Sleep Wake Disorders therapy, Deep Brain Stimulation methods, Parkinson Disease complications, Parkinson Disease physiopathology, Parkinson Disease therapy, Polysomnography
- Abstract
Study Objectives: A growing body of literature suggests that deep brain stimulation to treat motor symptoms of Parkinson's disease may also ameliorate certain sleep deficits. Many foundational studies have examined the impact of stimulation on sleep following several months of therapy, leaving an open question regarding the time course for improvement. It is unknown whether sleep improvement will immediately follow onset of therapy or accrete over a prolonged period of stimulation. The objective of our study was to address this knowledge gap by assessing the impact of deep brain stimulation on sleep macro-architecture during the first nights of stimulation., Methods: Polysomnograms were recorded for 3 consecutive nights in 14 patients with advanced Parkinson's disease (10 male, 4 female; age: 53-74 years), with intermittent, unilateral subthalamic nucleus deep brain stimulation on the final night or 2. Sleep scoring was determined manually by a consensus of 4 experts. Sleep macro-architecture was objectively quantified using the percentage, latency, and mean bout length of wake after sleep onset and on each stage of sleep (rapid eye movement and non-rapid eye movement stages 1, 2, 3)., Results: Sleep was found to be highly disrupted in all nights. Sleep architecture on nights without stimulation was consistent with prior results in treatment naive patients with Parkinson's disease. No statistically significant difference was observed due to stimulation., Conclusions: These objective measures suggest that 1 night of intermittent subthreshold stimulation appears insufficient to impact sleep macro-architecture., Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease; URL: https://clinicaltrials.gov/ct2/show/NCT04620551; Identifier: NCT04620551., Citation: Das R, Gliske SV, West LC, et al. Sleep macro-architecture in patients with Parkinson's disease does not change during the first night of neurostimulation in a pilot study. J Clin Sleep Med . 2024;20(9):1489-1496., (© 2024 American Academy of Sleep Medicine.)
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- 2024
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23. Using standardized ultrasound imaging to correlate OSA severity with tongue morphology.
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Bosschieter PFN, Liu SYC, Chao PY, Chen A, and Kushida CA
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- Humans, Female, Male, Adult, Prospective Studies, Middle Aged, Tongue diagnostic imaging, Tongue pathology, Sleep Apnea, Obstructive diagnostic imaging, Ultrasonography methods, Severity of Illness Index, Polysomnography
- Abstract
Background: Ultrasound imaging has been explored as a potential diagnostic tool for obstructive sleep apnea (OSA); we reported backscatter ultrasound imaging (BUI) of the tongue correlates with OSA severity in adults. We focus on anatomical features of the tongue using standardized ultrasonography and hypothesize that differences in morphology correlate with OSA severity., Methods: This prospective study was IRB approved (53,172) and conducted at Stanford University Sleep Surgery Clinic. Patients ≥18 years with polysomnography (PSG) underwent a standardized submental ultrasound scan using a laser alignment tool to observe the upper airway in supine position during tidal respiration. Images acquired from this scan were divided into 4 equiangular regions (A-D)., Results: A total of 144 patients (30 women) July 2020-December 2022 were included with mean age 41.6 years (±12.9 SD), BMI 27.2 kg/m
2 (±4.7 SD), and AHI 19.7 (±20.0 SD). Moderate-to-severe OSA patients had significantly narrower airspace at regions A, B and C with p-values ranging from <0.0001 to 0.0003. These patients had a significantly wider (p = 0.0021-0.0045 for regions A, B and C) tongue and thicker (p = 0.0403 for region B) deep tissue. The predictive model to assess the risk of moderate-to-severe OSA achieved an area under the receiver operating characteristic curve of 0.839 (95 % CI: 0.769 to 0.895)., Conclusions: With standardized, computerized ultrasound imaging of the shape and configuration of the tongue, we identified regions that correlated well with OSA severity. Further research is needed to determine the clinical implications of such pathophysiological findings., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: P. Chao reports financial support was provided by Amcad Biomed Corportaion. A. Chen reports financial support was provided by Amcad Biomed Corporation. P.F.N. Bosschieter reports a relationship with Amcad Biomed Corporation that includes: travel reimbursement. Dr. S. Liu reports a relationship with Amcad Biomed Corporation that includes: funding grants. Dr. S. Liu reports a relationship with Orchard Ultrasound that includes: non-financial support. Dr. A. Chen reports a relationship with Taiwan's National Science and Technology Council that includes: consulting or advisory and funding grants. P. Chao has patent Computer-Implemented Method for Predicting the Risk of Obstructive Sleep Apnea pending to P. Chao. A. Chen has patent Computer-Implemented Method for Predicting the Risk of Obstructive Sleep Apnea pending to P. Chen. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)- Published
- 2024
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24. Improvement in sleep latency with extended-release once-nightly sodium oxybate for the treatment of adults with narcolepsy: Analysis from the phase 3 REST-ON clinical trial.
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Thorpy MJ, Kushida CA, Bogan R, Winkelman J, Ohayon MM, Shapiro CM, and Gudeman J
- Abstract
Background: In the REST-ON clinical trial (NCT02720744), mean sleep latency on the Maintenance of Wakefulness Test (MWT) was significantly improved with extended-release once-nightly sodium oxybate (ON-SXB) vs placebo ( P < 0.001) in participants with narcolepsy. This post hoc analysis assessed response to treatment and improvement in excessive daytime sleepiness., Methods: Participants with narcolepsy aged ≥16 years were randomized 1:1 to receive ON-SXB (4.5 g, week 1; 6 g, weeks 2-3; 7.5 g, weeks 3-8; and 9 g, weeks 9-13) or placebo. Mean sleep latency on the MWT was measured across 5 trials of ≤30 min each. Post hoc assessments included percentage of participants whose sleep latency improved ≥5, ≥10, ≥15, and ≥20 min and with a mean sleep latency of 30 min., Results: Significantly more participants receiving ON-SXB vs placebo experienced increased mean sleep latency ≥5 min (all doses P < 0.001), ≥10 min (all doses P < 0.001), ≥15 min (6 and 7.5 g, P < 0.001; 9 g, P < 0.01), and ≥20 min (6 g, P < 0.01; 7.5 g, P < 0.001; 9 g, P < 0.05). More participants receiving ON-SXB had mean sleep latency of 30 min vs placebo (6 g, 5.7 % vs 0 %, respectively [ P < 0.05]; 7.5 g, 10.5 % vs 1.3 % [ P < 0.05]; 9 g, 13.2 % vs 5.1 % [ P = 0.143])., Conclusions: Significantly more participants who received ON-SXB experienced increased mean sleep latency ≥5 to ≥20 min; at the 2 highest doses, >10 % remained awake for the entirety of the MWT. ON-SXB offers a once-at-bedtime treatment option for adults with narcolepsy., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Michael J. Thorpy reports a relationship with Axsome Therapeutics that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Balance Therapeutics that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Eisai that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Harmony BioSciences that includes: consulting or advisory. Michael J. Thorpy reports a relationship with 10.13039/100011096Jazz Pharmaceuticals that includes: consulting or advisory. Michael J. Thorpy reports a relationship with NLS Pharmaceuticals that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Suven Life Sciences Ltd. that includes: consulting or advisory. Michael J. Thorpy reports a relationship with 10.13039/100008373Takeda Pharmaceutical Co that includes: consulting or advisory. Clete A. Kushida reports a relationship with Avadel Pharmaceutical that includes: consulting. Clete A. Kushida reports a relationship with XW Pharma that includes: consulting. Richard Bogan reports a relationship with WaterMark Medical and Health Humming LLC that includes: equity or stocks. Richard Bogan reports a relationship with WaterMark Medical that includes: board membership. Richard Bogan reports a relationship with 10.13039/100011096Jazz Pharmaceuticals that includes: consulting or advisory, funding grants, and speaking and lecture fees. Richard Bogan reports a relationship with Harmony BioSciences that includes: consulting or advisory and speaking and lecture fees. Richard Bogan reports a relationship with 10.13039/100008373Takeda Pharmaceutical Co. that includes: consulting or advisory and funding grants. Richard Bogan reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory and funding grants. Richard Bogan reports a relationship with Oventus that includes: consulting or advisory. Richard Bogan reports a relationship with BresoTec that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100004326Bayer that includes: funding grants. Richard Bogan reports a relationship with 10.13039/501100016198Idorsia that includes: funding grants. Richard Bogan reports a relationship with Suven Life Sciences Ltd. that includes: funding grants. Richard Bogan reports a relationship with Balance Therapeutics that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100010902Vanda that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100004334Merck that includes: funding grants. Richard Bogan reports a relationship with 10.13039/501100003769Eisai that includes: funding grants and speaking and lecture fees. Richard Bogan reports a relationship with Fresca that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100013410LivaNova that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100004337Roche that includes: funding grants. Richard Bogan reports a relationship with Sommetrics that includes: funding grants. John Winkelman reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory. John Winkelman reports a relationship with Emalex Biosciences that includes: consulting or advisory. John Winkelman reports a relationship with Noctrix Health that includes: consulting or advisory. John Winkelman reports a relationship with Disc Medicine that includes: consulting or advisory. John Winkelman reports a relationship with 10.13039/501100016198Idorsia Pharmaceuticals that includes: consulting or advisory. John Winkelman reports a relationship with 10.13039/100004334Merck & Co. that includes: funding grants. John Winkelman reports a relationship with 10.13039/100016473American Regent that includes: funding grants. John Winkelman reports a relationship with 10.13039/100000026NIDA that includes: funding grants. John Winkelman reports a relationship with 10.13039/100004087RLS Foundation that includes: funding grants. John Winkelman reports a relationship with Baszucki Brain Research Fund that includes: funding grants. Maurice M. Ohayon reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory. Maurice M. Ohayon reports a relationship with 10.13039/100008373Takeda Pharmaceutical Co. that includes: consulting or advisory. Maurice M. Ohayon reports a relationship with Jazz Pharmaceuticals that includes: consulting or advisory. Colin M. Shapiro reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory and speaking and lecture fees. Colin M. Shapiro reports a relationship with 10.13039/100011096Jazz Pharmaceuticals that includes: consulting or advisory and speaking and lecture fees. Jennifer Gudeman reports a relationship with Avadel Pharmaceuticals that includes: employment. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)
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- 2024
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25. Cataplexy response with extended-release once-nightly sodium oxybate: Post hoc responder analyses from the phase 3 REST-ON clinical trial.
- Author
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Thorpy MJ, Kushida CA, Bogan R, Ajayi AO, Corser BC, and Gudeman J
- Abstract
Background: Once-nightly sodium oxybate (ON-SXB), an extended-release oxybate formulation, yielded significant ( P < 0.001 at 6 g, 7.5 g, and 9 g) reductions in cataplexy episodes in participants in the phase 3 REST-ON clinical trial (NCT02720744). This post hoc analysis from REST-ON further characterized changes in cataplexy episodes in participants with narcolepsy type 1 (NT1)., Methods: Participants with narcolepsy aged ≥16 years received ON-SXB (1 wk, 4.5 g; 2 wk, 6 g; 5 wk, 7.5 g; 5 wk, 9 g) or placebo. Percentages of participants with NT1 who had ≥25%, ≥50%, ≥75%, and 100% reductions from baseline in mean number of weekly cataplexy episodes were determined. Two-sided P values comparing ON-SXB vs placebo were calculated with Fisher exact test., Results: Participants with NT1 (ON-SXB, n = 73; placebo, n = 72; modified intent-to-treat population) had a baseline mean number of weekly cataplexy episodes of 18.9 (ON-SXB) and 19.8 (placebo). Of participants receiving the highest doses of ON-SXB (7.5 and 9 g), approximately half had a 50% reduction, one-third had a 75% reduction, and one-tenth had a 100% reduction in their cataplexy episodes vs placebo. Significantly greater proportions of participants receiving ON-SXB vs placebo had respective reductions in weekly cataplexy episodes of ≥25% at weeks 1 (4.5 g; P < 0.05), 3 (6 g; P < 0.001), 8 (7.5 g; P < 0.001), and 13 (9 g; P = 0.001)., Conclusions: A significantly greater proportion of participants receiving ON-SXB vs placebo experienced reductions in weekly cataplexy episodes at all tested doses. Approximately 10% of participants taking the 2 highest ON-SXB doses had complete elimination of their cataplexy., Competing Interests: Michael J. Thorpy reports a relationship with Axsome Therapeutics Inc that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Balance Therapeutics that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Eisai that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Harmony Biosciences that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Jazz Pharmaceuticals that includes: consulting or advisory. Michael J. Thorpy reports a relationship with NLS Pharmaceuticals that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Suven Life Sciences Ltd. that includes: consulting or advisory. Michael J. Thorpy reports a relationship with Takeda Pharmaceutical Co that includes: consulting or advisory. Clete A. Kushida reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory. Clete A. Kushida reports a relationship with XW Pharma that includes: consulting or advisory. Richard Bogan reports a relationship with WaterMark Medical and Healthy Humming, LLC that includes: equity or stocks. Richard Bogan reports a relationship with WaterMark Medical that includes: board membership. Richard Bogan reports a relationship with 10.13039/100011096Jazz Pharmaceuticals that includes: consulting or advisory, funding grants, and speaking and lecture fees. Richard Bogan reports a relationship with 10.13039/100007723Takeda Pharmaceutical Co. that includes: consulting or advisory and funding grants. Richard Bogan reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory and funding grants. Richard Bogan reports a relationship with Oventus that includes: consulting or advisory. Richard Bogan reports a relationship with BresoTec that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100004326Bayer that includes: funding grants. Richard Bogan reports a relationship with 10.13039/501100016198Idorsia that includes: funding grants. Richard Bogan reports a relationship with Suven Life Sciences Ltd that includes: funding grants. Richard Bogan reports a relationship with Balance that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100010902Vanda that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100004334Merck & Co., Inc that includes: funding grants. Richard Bogan reports a relationship with 10.13039/501100003769Eisai that includes: funding grants and speaking and lecture fees. Richard Bogan reports a relationship with 10.13039/100004320Philips that includes: funding grants. Richard Bogan reports a relationship with FRESCA Medical that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100013410LivaNova that includes: funding grants. Richard Bogan reports a relationship with 10.13039/100004337Roche that includes: funding grants. Richard Bogan reports a relationship with Sommetrics that includes: funding grants. Richard Bogan reports a relationship with Harmony Biosciences that includes: speaking and lecture fees. Akinyemi O. Ajayi reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory. Bruce C. Corser reports a relationship with 10.13039/100011096Jazz Pharmaceuticals that includes: speaking and lecture fees. Bruce C. Corser reports a relationship with 10.13039/100004334Merck & Co., Inc that includes: speaking and lecture fees. Bruce C. Corser reports a relationship with 10.13039/501100003769Eisai that includes: speaking and lecture fees. Bruce C. Corser reports a relationship with Harmony Biosciences that includes: speaking and lecture fees. Bruce C. Corser reports a relationship with Avadel Pharmaceuticals that includes: consulting or advisory and speaking and lecture fees. Jennifer Gudeman reports a relationship with Avadel Pharmaceuticals that includes: employment. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)
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- 2024
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26. Proteomic insights into the pathophysiology of periodic limb movements and restless legs syndrome.
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Cederberg KLJ, Peris Sempere V, Lin L, Zhang J, Leary EB, Moore H, Morse AM, Blackman A, Schweitzer PK, Kotagal S, Bogan R, Kushida CA, and Mignot E
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- Adult, Humans, Hepcidins, Proteomics, Cathepsin A, Iron, Ferritins, Restless Legs Syndrome, Nocturnal Myoclonus Syndrome
- Abstract
Objectives: We used a high-throughput assay of 5000 plasma proteins to identify biomarkers associated with periodic limb movements (PLM) and restless legs syndrome (RLS) in adults., Methods: Participants (n = 1410) of the Stanford Technology Analytics and Genomics in Sleep (STAGES) study had blood collected, completed a sleep questionnaire, and underwent overnight polysomnography with the scoring of PLMs. An aptamer-based array (SomaScan) was used to quantify 5000 proteins in plasma. A second cohort (n = 697) that had serum assayed using a previous iteration of SomaScan (1300 proteins) was used for replication and in a combined analysis (n = 2107). A 5% false discovery rate was used to assess significance., Results: Multivariate analyses in STAGES identified 68 proteins associated with the PLM index after correction for multiple testing (ie, base model). Most significantly decreased proteins were iron-related and included Hepcidin (LEAP-1), Ferritin, and Ferritin light chain. Most significantly increased proteins included RANTES, Cathepsin A, and SULT 1A3. Of 68 proteins significant in the base model, 17 were present in the 1300 panel, and 15 of 17 were replicated. The most significant proteins in the combined model were Hepcidin (LEAP-1), Cathepsin A, Ferritin, and RANTES. Exploration of proteins in RLS versus non-RLS identified Cathepsin Z, Heme oxygenase 2 (HO-2), Interleukin-17A (upregulated in the combined cohort), and Megalin (upregulated in STAGES only) although results were less significant than for proteins associated with PLM index., Conclusions: These results confirm the association of PLM with low iron status and suggest the involvement of catabolic enzymes in PLM/RLS., (Copyright © 2024 National Sleep Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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27. Once-nightly sodium oxybate (FT218) improved symptoms of disrupted nighttime sleep in people with narcolepsy: a plain language summary.
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Roth T, Thorpy MJ, Kushida CA, Horsnell M, and Gudeman J
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- Adult, United States, Humans, Sleep, United States Food and Drug Administration, Sodium Oxybate therapeutic use, Sodium Oxybate pharmacology, Narcolepsy drug therapy, Narcolepsy complications, Narcolepsy diagnosis, Cataplexy drug therapy, Cataplexy complications, Cataplexy diagnosis
- Abstract
What Is This Summary About?: This is a plain language summary of a published article in the journal CNS Drugs . Narcolepsy is a rare sleep condition. Most people with narcolepsy experience disrupted nighttime sleep and have poor quality of sleep. Sometimes these symptoms are not easily diagnosed as a symptom of narcolepsy. Sodium oxybate is an approved treatment for narcolepsy. The only version of sodium oxybate that was available until 2023 required people to take their sodium oxybate at bedtime and then again in the middle of the night. The US Food and Drug Administration (FDA for short) has approved a once-nightly bedtime dose of sodium oxybate (ON-SXB for short, also known as FT218 or LUMRYZ
™ ) to treat symptoms of narcolepsy in adults. These symptoms are daytime sleepiness and cataplexy, which is an episode of sudden muscle weakness. The once-nightly bedtime dose of ON-SXB removes the need for a middle-of-the-night dose of sodium oxybate. The REST-ON clinical study compared ON-SXB to a placebo (a substance that contains no medicine) to determine if it was better at treating symptoms of disrupted nighttime sleep associated with narcolepsy. This summary looks at whether; ON-SXB was better than placebo at treating symptoms of disrupted nighttime sleep., What Were the Results?: Compared to people who took placebo, people who took ON-SXB had fewer number of changes from deeper to lighter sleep stages and woke up less during the night. They also reported that they slept better at night and felt more refreshed when waking up in the morning. People with narcolepsy sometimes take alerting agents to help with sleepiness during the day, but alerting agents can cause difficulty sleeping at night. This study showed that people who took ON-SXB had better nighttime sleep even if they were taking alerting agents during the day. The most common side effects of ON-SXB included dizziness, nausea (feeling sick to your stomach), vomiting, headache, and bedwetting., What Do the Results Mean?: A once-nightly bedtime dose of ON-SXB is a narcolepsy treatment option for people without the need for a middle-of-the-night dose of sodium oxybate.- Published
- 2023
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28. An approach for determining the reliability of manual and digital scoring of sleep stages.
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Gerardy B, Kuna ST, Pack A, Kushida CA, Walsh JK, Staley B, Pien GW, and Younes M
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- Humans, Reproducibility of Results, Observer Variation, Polysomnography methods, Electroencephalography, Sleep Stages, Sleep
- Abstract
Study Objectives: Inter-scorer variability in sleep staging is largely due to equivocal epochs that contain features of more than one stage. We propose an approach that recognizes the existence of equivocal epochs and evaluates scorers accordingly., Methods: Epoch-by-epoch staging was performed on 70 polysomnograms by six qualified technologists and by a digital system (Michele Sleep Scoring [MSS]). Probability that epochs assigned the same stage by only two of the six technologists (minority score) resulted from random occurrence of two errors was calculated and found to be <5%, thereby indicating that the stage assigned is an acceptable variant for the epoch. Acceptable stages were identified in each epoch as stages assigned by at least two technologists. Percent agreement between each technologist and the other five technologists, acting as judges, was determined. Agreement was considered to exist if the stage assigned by the tested scorer was one of the acceptable stages for the epoch. Stage assigned by MSS was likewise considered in agreement if included in the acceptable stages made by the technologists., Results: Agreement of technologists tested against five qualified judges increased from 80.8% (range 70.5%-86.4% among technologists) when using the majority rule, to 96.1 (89.8%-98.5%) by the proposed approach. Agreement between unedited MSS and same judges was 90.0% and increased to 92.1% after brief editing., Conclusions: Accounting for equivocal epochs provides a more accurate estimate of a scorer's (human or digital) competence in scoring sleep stages and reduces inter-scorer disagreements. The proposed approach can be implemented in sleep-scoring training and accreditation programs., (© The Author(s) 2023. Published by Oxford University Press on behalf of Sleep Research Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2023
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29. Accuracy of 11 Wearable, Nearable, and Airable Consumer Sleep Trackers: Prospective Multicenter Validation Study.
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Lee T, Cho Y, Cha KS, Jung J, Cho J, Kim H, Kim D, Hong J, Lee D, Keum M, Kushida CA, Yoon IY, and Kim JW
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- Humans, Female, Male, Prospective Studies, Polysomnography, Fitness Trackers, Sleep, Sleep Stages
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Background: Consumer sleep trackers (CSTs) have gained significant popularity because they enable individuals to conveniently monitor and analyze their sleep. However, limited studies have comprehensively validated the performance of widely used CSTs. Our study therefore investigated popular CSTs based on various biosignals and algorithms by assessing the agreement with polysomnography., Objective: This study aimed to validate the accuracy of various types of CSTs through a comparison with in-lab polysomnography. Additionally, by including widely used CSTs and conducting a multicenter study with a large sample size, this study seeks to provide comprehensive insights into the performance and applicability of these CSTs for sleep monitoring in a hospital environment., Methods: The study analyzed 11 commercially available CSTs, including 5 wearables (Google Pixel Watch, Galaxy Watch 5, Fitbit Sense 2, Apple Watch 8, and Oura Ring 3), 3 nearables (Withings Sleep Tracking Mat, Google Nest Hub 2, and Amazon Halo Rise), and 3 airables (SleepRoutine, SleepScore, and Pillow). The 11 CSTs were divided into 2 groups, ensuring maximum inclusion while avoiding interference between the CSTs within each group. Each group (comprising 8 CSTs) was also compared via polysomnography., Results: The study enrolled 75 participants from a tertiary hospital and a primary sleep-specialized clinic in Korea. Across the 2 centers, we collected a total of 3890 hours of sleep sessions based on 11 CSTs, along with 543 hours of polysomnography recordings. Each CST sleep recording covered an average of 353 hours. We analyzed a total of 349,114 epochs from the 11 CSTs compared with polysomnography, where epoch-by-epoch agreement in sleep stage classification showed substantial performance variation. More specifically, the highest macro F1 score was 0.69, while the lowest macro F1 score was 0.26. Various sleep trackers exhibited diverse performances across sleep stages, with SleepRoutine excelling in the wake and rapid eye movement stages, and wearables like Google Pixel Watch and Fitbit Sense 2 showing superiority in the deep stage. There was a distinct trend in sleep measure estimation according to the type of device. Wearables showed high proportional bias in sleep efficiency, while nearables exhibited high proportional bias in sleep latency. Subgroup analyses of sleep trackers revealed variations in macro F1 scores based on factors, such as BMI, sleep efficiency, and apnea-hypopnea index, while the differences between male and female subgroups were minimal., Conclusions: Our study showed that among the 11 CSTs examined, specific CSTs showed substantial agreement with polysomnography, indicating their potential application in sleep monitoring, while other CSTs were partially consistent with polysomnography. This study offers insights into the strengths of CSTs within the 3 different classes for individuals interested in wellness who wish to understand and proactively manage their own sleep., (©Taeyoung Lee, Younghoon Cho, Kwang Su Cha, Jinhwan Jung, Jungim Cho, Hyunggug Kim, Daewoo Kim, Joonki Hong, Dongheon Lee, Moonsik Keum, Clete A Kushida, In-Young Yoon, Jeong-Whun Kim. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 02.11.2023.)
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- 2023
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30. Sodium oxybate in treatment-resistant rapid-eye-movement sleep behavior disorder.
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During EH, Hernandez B, Miglis MG, Sum-Ping O, Hekmat A, Cahuas A, Ekelmans A, Yoshino F, Mignot E, and Kushida CA
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- Adult, Humans, Sleep, Anxiety, Anxiety Disorders, REM Sleep Behavior Disorder complications, REM Sleep Behavior Disorder drug therapy, Sodium Oxybate therapeutic use
- Abstract
Study Objectives: Symptomatic therapies for rapid-eye-movement (REM) sleep behavior disorder (RBD) are limited. Sodium oxybate (SXB), a gamma-aminobutyric acid (GABA)-B agonist, could be effective but has not been evaluated against placebo., Methods: This double-blind, parallel-group, randomized, placebo-controlled trial in 24 participants was conducted at the Stanford Sleep Center. Patients were adults with definite iRBD or Parkinson's disease and probable RBD (PD-RBD), and persistence of ≥ 2 weekly episodes despite standard therapy. Patients were randomized 1:1 to receive SXB during a 4-week titration followed by a 4-week stable dosing period. Primary outcome was number of monthly RBD episodes according to a diary filled by patients and partners. Secondary outcomes were severity, number of severe RBD episodes, and objective RBD activity on video polysomnography., Results: Twelve iRBD and 12 PD-RBD participated (mean 65.8 years), and 22 (n = 10 SXB, 12 placebo) completed the study. Although no significant between-group difference was found, SXB showed reduction of monthly RBD episodes by 23.1 (95% CI -36.0, -10.2; p = 0.001) versus 10.5 with placebo (95% CI, -22.6, 1.6; p = 0.087). Improvement from baseline was similarly observed for RBD overall severity burden (each episode weighted for severity), number of severe episodes, and objective RBD activity per video-polysomnography. Two participants receiving SXB withdrew due to anxiety and dizziness. The majority of adverse events are otherwise resolved with dose adjustment., Conclusion: SXB could reduce RBD symptoms; however, response was inconsistent and a large placebo effect was observed across patient-reported outcomes. Larger studies using objective endpoints are needed., Clinical Trial: Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate https://clinicaltrials.gov/ct2/show/NCT04006925 ClinicalTrials.gov identifier: NCT04006925., (© Sleep Research Society 2023. Published by Oxford University Press on behalf of the Sleep Research Society.)
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- 2023
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31. International Consensus Statement on Obstructive Sleep Apnea.
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Chang JL, Goldberg AN, Alt JA, Mohammed A, Ashbrook L, Auckley D, Ayappa I, Bakhtiar H, Barrera JE, Bartley BL, Billings ME, Boon MS, Bosschieter P, Braverman I, Brodie K, Cabrera-Muffly C, Caesar R, Cahali MB, Cai Y, Cao M, Capasso R, Caples SM, Chahine LM, Chang CP, Chang KW, Chaudhary N, Cheong CSJ, Chowdhuri S, Cistulli PA, Claman D, Collen J, Coughlin KC, Creamer J, Davis EM, Dupuy-McCauley KL, Durr ML, Dutt M, Ali ME, Elkassabany NM, Epstein LJ, Fiala JA, Freedman N, Gill K, Gillespie MB, Golisch L, Gooneratne N, Gottlieb DJ, Green KK, Gulati A, Gurubhagavatula I, Hayward N, Hoff PT, Hoffmann OMG, Holfinger SJ, Hsia J, Huntley C, Huoh KC, Huyett P, Inala S, Ishman SL, Jella TK, Jobanputra AM, Johnson AP, Junna MR, Kado JT, Kaffenberger TM, Kapur VK, Kezirian EJ, Khan M, Kirsch DB, Kominsky A, Kryger M, Krystal AD, Kushida CA, Kuzniar TJ, Lam DJ, Lettieri CJ, Lim DC, Lin HC, Liu SYC, MacKay SG, Magalang UJ, Malhotra A, Mansukhani MP, Maurer JT, May AM, Mitchell RB, Mokhlesi B, Mullins AE, Nada EM, Naik S, Nokes B, Olson MD, Pack AI, Pang EB, Pang KP, Patil SP, Van de Perck E, Piccirillo JF, Pien GW, Piper AJ, Plawecki A, Quigg M, Ravesloot MJL, Redline S, Rotenberg BW, Ryden A, Sarmiento KF, Sbeih F, Schell AE, Schmickl CN, Schotland HM, Schwab RJ, Seo J, Shah N, Shelgikar AV, Shochat I, Soose RJ, Steele TO, Stephens E, Stepnowsky C, Strohl KP, Sutherland K, Suurna MV, Thaler E, Thapa S, Vanderveken OM, de Vries N, Weaver EM, Weir ID, Wolfe LF, Woodson BT, Won CHJ, Xu J, Yalamanchi P, Yaremchuk K, Yeghiazarians Y, Yu JL, Zeidler M, and Rosen IM
- Subjects
- Adult, Humans, Continuous Positive Airway Pressure methods, Polysomnography methods, Risk Factors, Sleep Apnea, Obstructive diagnosis, Sleep Apnea, Obstructive epidemiology, Sleep Apnea, Obstructive therapy
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Background: Evaluation and interpretation of the literature on obstructive sleep apnea (OSA) allows for consolidation and determination of the key factors important for clinical management of the adult OSA patient. Toward this goal, an international collaborative of multidisciplinary experts in sleep apnea evaluation and treatment have produced the International Consensus statement on Obstructive Sleep Apnea (ICS:OSA)., Methods: Using previously defined methodology, focal topics in OSA were assigned as literature review (LR), evidence-based review (EBR), or evidence-based review with recommendations (EBR-R) formats. Each topic incorporated the available and relevant evidence which was summarized and graded on study quality. Each topic and section underwent iterative review and the ICS:OSA was created and reviewed by all authors for consensus., Results: The ICS:OSA addresses OSA syndrome definitions, pathophysiology, epidemiology, risk factors for disease, screening methods, diagnostic testing types, multiple treatment modalities, and effects of OSA treatment on multiple OSA-associated comorbidities. Specific focus on outcomes with positive airway pressure (PAP) and surgical treatments were evaluated., Conclusion: This review of the literature consolidates the available knowledge and identifies the limitations of the current evidence on OSA. This effort aims to create a resource for OSA evidence-based practice and identify future research needs. Knowledge gaps and research opportunities include improving the metrics of OSA disease, determining the optimal OSA screening paradigms, developing strategies for PAP adherence and longitudinal care, enhancing selection of PAP alternatives and surgery, understanding health risk outcomes, and translating evidence into individualized approaches to therapy., (© 2022 ARS-AAOA, LLC.)
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- 2023
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32. Evaluation of consensus sleep stage scoring of dysregulated sleep in Parkinson's disease.
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West LC, Summers M, Tang S, Hirt L, Halpern CH, Maroni D, Das R, Gliske SV, Abosch A, Kushida CA, and Thompson JA
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- Humans, Consensus, Observer Variation, Reproducibility of Results, Sleep, Sleep Stages physiology, Parkinson Disease complications
- Abstract
Objective: Sleep dysregulation in Parkinson's disease (PD) has been hypothesized to occur, in part, from dysfunction in the basal ganglia-cortical circuit. Assessment of this relationship requires accurate sleep stage determination, a known challenge in this clinical population. Our objective was to optimize the consensus on the sleep staging process and reduce interrater variability in a cohort of advanced PD subjects., Methods: Fifteen PD subjects were enrolled from three sites in a clinical trial that involved recordings from subthalamic nucleus (STN) deep brain stimulation (DBS) leads (NCT04620551). Video polysomnography (vPSG) data for a total of 45 nights were analyzed. Four experienced scorers independently scored data on initial review. Epochs with less than 75% consensus were flagged for secondary review. In secondary review of discordant epochs, two of the original scorers re-assessed epochs, from which the final consensus stage was derived., Results: Sleep stage classification agreement averaged 83.10% across all sleep stages on initial scoring (IS), and on secondary consensus scoring (CS) review, agreement reached 96.58%. Greatest disagreement was noted in determination of awake epochs (33.6% of discordant epochs) and non-rapid-eye-movement stage 2 (N2) epochs (31.8% of discordant epochs). Scoring discrepancy was resolved with direct measurement of cortical frequency and amplitudes, physiologic context of the epoch, and video review., Conclusion: Our method of multi-level initial and then secondary consensus review scoring resulted in consensus scoring agreement superior to conventional standards. This work features a custom-engineered vPSG software and review platform for integration of consensus sleep stage scoring in a multi-site clinical trial., Competing Interests: Declaration of competing interest ad hoc consulting for Medtronic for A. Abosch., (Copyright © 2023 Elsevier B.V. All rights reserved.)
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- 2023
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33. Prediction of Sleep Stages Via Deep Learning Using Smartphone Audio Recordings in Home Environments: Model Development and Validation.
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Tran HH, Hong JK, Jang H, Jung J, Kim J, Hong J, Lee M, Kim JW, Kushida CA, Lee D, Kim D, and Yoon IY
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- Humans, Sound Recordings, Home Environment, Sleep Stages, Sleep, Smartphone, Deep Learning
- Abstract
Background: The growing public interest and awareness regarding the significance of sleep is driving the demand for sleep monitoring at home. In addition to various commercially available wearable and nearable devices, sound-based sleep staging via deep learning is emerging as a decent alternative for their convenience and potential accuracy. However, sound-based sleep staging has only been studied using in-laboratory sound data. In real-world sleep environments (homes), there is abundant background noise, in contrast to quiet, controlled environments such as laboratories. The use of sound-based sleep staging at homes has not been investigated while it is essential for practical use on a daily basis. Challenges are the lack of and the expected huge expense of acquiring a sufficient size of home data annotated with sleep stages to train a large-scale neural network., Objective: This study aims to develop and validate a deep learning method to perform sound-based sleep staging using audio recordings achieved from various uncontrolled home environments., Methods: To overcome the limitation of lacking home data with known sleep stages, we adopted advanced training techniques and combined home data with hospital data. The training of the model consisted of 3 components: (1) the original supervised learning using 812 pairs of hospital polysomnography (PSG) and audio recordings, and the 2 newly adopted components; (2) transfer learning from hospital to home sounds by adding 829 smartphone audio recordings at home; and (3) consistency training using augmented hospital sound data. Augmented data were created by adding 8255 home noise data to hospital audio recordings. Besides, an independent test set was built by collecting 45 pairs of overnight PSG and smartphone audio recording at homes to examine the performance of the trained model., Results: The accuracy of the model was 76.2% (63.4% for wake, 64.9% for rapid-eye movement [REM], and 83.6% for non-REM) for our test set. The macro F1-score and mean per-class sensitivity were 0.714 and 0.706, respectively. The performance was robust across demographic groups such as age, gender, BMI, or sleep apnea severity (accuracy 73.4%-79.4%). In the ablation study, we evaluated the contribution of each component. While the supervised learning alone achieved accuracy of 69.2% on home sound data, adding consistency training to the supervised learning helped increase the accuracy to a larger degree (+4.3%) than adding transfer learning (+0.1%). The best performance was shown when both transfer learning and consistency training were adopted (+7.0%)., Conclusions: This study shows that sound-based sleep staging is feasible for home use. By adopting 2 advanced techniques (transfer learning and consistency training) the deep learning model robustly predicts sleep stages using sounds recorded at various uncontrolled home environments, without using any special equipment but smartphones only., (©Hai Hong Tran, Jung Kyung Hong, Hyeryung Jang, Jinhwan Jung, Jongmok Kim, Joonki Hong, Minji Lee, Jeong-Whun Kim, Clete A Kushida, Dongheon Lee, Daewoo Kim, In-Young Yoon. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 01.06.2023.)
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- 2023
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34. Letter in reply: a letter to the editor commenting on the recent publication by AY Avidan and CA Kushida.
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Avidan AY and Kushida CA
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- 2023
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35. The polysomnographic diagnosis of REM sleep behavior disorder: to change or not to change, that is the question.
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Ferri R, Lewis SJG, De Cock VC, Tachibana N, Kushida CA, and Schenck CH
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- Humans, Sleep, REM, Electromyography, REM Sleep Behavior Disorder diagnosis
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- 2023
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36. The Link between Obstructive Sleep Apnea and Neurocognitive Impairment: An Official American Thoracic Society Workshop Report.
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Lal C, Ayappa I, Ayas N, Beaudin AE, Hoyos C, Kushida CA, Kaminska M, Mullins A, Naismith SL, Osorio RS, Phillips CL, Parekh A, Stone KL, Turner AD, and Varga AW
- Subjects
- Biomarkers, Continuous Positive Airway Pressure methods, Humans, Neuropsychological Tests, Alzheimer Disease, Sleep Apnea, Obstructive complications, Sleep Apnea, Obstructive therapy
- Abstract
There is emerging evidence that obstructive sleep apnea (OSA) is a risk factor for preclinical Alzheimer's disease (AD). An American Thoracic Society workshop was convened that included clinicians, basic scientists, and epidemiologists with expertise in OSA, cognition, and dementia, with the overall objectives of summarizing the state of knowledge in the field, identifying important research gaps, and identifying potential directions for future research. Although currently available cognitive screening tests may allow for identification of cognitive impairment in patients with OSA, they should be interpreted with caution. Neuroimaging in OSA can provide surrogate measures of disease chronicity, but it has methodological limitations. Most data on the impact of OSA treatment on cognition are for continuous positive airway pressure (CPAP), with limited data for other treatments. The cognitive domains improving with CPAP show considerable heterogeneity across studies. OSA can negatively influence risk, manifestations, and possibly progression of AD and other forms of dementia. Sleep-dependent memory tasks need greater incorporation into OSA testing, with better delineation of sleep fragmentation versus intermittent hypoxia effects. Plasma biomarkers may prove to be sensitive, feasible, and scalable biomarkers for use in clinical trials. There is strong biological plausibility, but insufficient data, to prove bidirectional causality of the associations between OSA and aging pathology. Engaging, recruiting, and retaining diverse populations in health care and research may help to decrease racial and ethnic disparities in OSA and AD. Key recommendations from the workshop include research aimed at underlying mechanisms; longer-term longitudinal studies with objective assessment of OSA, sensitive cognitive markers, and sleep-dependent cognitive tasks; and pragmatic study designs for interventional studies that control for other factors that may impact cognitive outcomes and use novel biomarkers.
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- 2022
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37. Proteomic Biomarkers of the Apnea Hypopnea Index and Obstructive Sleep Apnea: Insights into the Pathophysiology of Presence, Severity, and Treatment Response.
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Cederberg KLJ, Hanif U, Peris Sempere V, Hédou J, Leary EB, Schneider LD, Lin L, Zhang J, Morse AM, Blackman A, Schweitzer PK, Kotagal S, Bogan R, Kushida CA, Ju YS, Petousi N, Turnbull CD, Mignot E, and The Stages Cohort Investigator Group
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- Biomarkers, Continuous Positive Airway Pressure, Humans, Polysomnography, Proteomics, Sleep Apnea, Obstructive complications, Sleep Apnea, Obstructive diagnosis, Sleep Apnea, Obstructive therapy
- Abstract
Obstructive sleep apnea (OSA), a disease associated with excessive sleepiness and increased cardiovascular risk, affects an estimated 1 billion people worldwide. The present study examined proteomic biomarkers indicative of presence, severity, and treatment response in OSA. Participants (n = 1391) of the Stanford Technology Analytics and Genomics in Sleep study had blood collected and completed an overnight polysomnography for scoring the apnea−hypopnea index (AHI). A highly multiplexed aptamer-based array (SomaScan) was used to quantify 5000 proteins in all plasma samples. Two separate intervention-based cohorts with sleep apnea (n = 41) provided samples pre- and post-continuous/positive airway pressure (CPAP/PAP). Multivariate analyses identified 84 proteins (47 positively, 37 negatively) associated with AHI after correction for multiple testing. Of the top 15 features from a machine learning classifier for AHI ≥ 15 vs. AHI < 15 (Area Under the Curve (AUC) = 0.74), 8 were significant markers of both AHI and OSA from multivariate analyses. Exploration of pre- and post-intervention analysis identified 5 of the 84 proteins to be significantly decreased following CPAP/PAP treatment, with pathways involving endothelial function, blood coagulation, and inflammatory response. The present study identified PAI-1, tPA, and sE-Selectin as key biomarkers and suggests that endothelial dysfunction and increased coagulopathy are important consequences of OSA, which may explain the association with cardiovascular disease and stroke.
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- 2022
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38. Once-nightly sodium oxybate (FT218) demonstrated improvement of symptoms in a phase 3 randomized clinical trial in patients with narcolepsy.
- Author
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Kushida CA, Shapiro CM, Roth T, Thorpy MJ, Corser BC, Ajayi AO, Rosenberg R, Roy A, Seiden D, Dubow J, and Dauvilliers Y
- Subjects
- Double-Blind Method, Humans, Sleepiness, Treatment Outcome, Wakefulness, Cataplexy drug therapy, Narcolepsy drug therapy, Sodium Oxybate adverse effects
- Abstract
Study Objectives: To assess the efficacy and safety of FT218, a novel once-nightly formulation of sodium oxybate (ON-SXB), in patients with narcolepsy in the phase 3 REST-ON trial., Methods: Narcolepsy patients aged ≥16 years were randomized 1:1 to uptitration of ON-SXB (4.5, 6, 7.5, and 9 g) or placebo. Three coprimary endpoints were change from baseline in mean sleep latency on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement rating, and weekly cataplexy attacks at 9, 7.5, and 6 g. Secondary endpoints included change from baseline on the Epworth Sleepiness Scale. Safety included adverse drug reactions and clinical laboratory assessments., Results: In total, 222 patients were randomized; 212 received ≥1 dose of ON-SXB (n = 107) or placebo (n = 105). For the three coprimary endpoints and Epworth Sleepiness Scale, all three doses of ON-SXB demonstrated clinically meaningful, statistically significant improvement versus placebo (all p < 0.001). For ON-SXB 9 g versus placebo, increase in mean sleep latency was 10.8 versus 4.7 min (Least squares mean difference, LSMD [95% CI], 6.13 [3.52 to 8.75]), 72.0% versus 31.6% were rated much/very much improved on Clinical Global Impression-Improvement (OR [95% CI], 5.56 [2.76 to 11.23]), change in mean weekly number of cataplexy attacks was -11.5 versus -4.9 (LSMD [95% CI], -6.65 [-9.32 to -3.98]), and change in Epworth Sleepiness Scale was -6.5 and -2.7 (LSMD [95% CI], -6.52 [-5.47 to -2.26]). Common adverse reactions included nausea, vomiting, headache, dizziness, and enuresis., Conclusions: ON-SXB significantly improved narcolepsy symptoms; its safety profile was consistent with SXB. ON-SXB conferred efficacy with a clearly beneficial single nighttime dose., Clinical Trial Registration: ClinicalTrials.gov: NCT02720744, https://clinicaltrials.gov/ct2/show/NCT02720744., (© Sleep Research Society 2021. Published by Oxford University Press on behalf of the Sleep Research Society.)
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- 2022
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39. Response to: Once-nightly sodium oxybate (FT218) in the treatment of narcolepsy: a letter to the editor commenting on the recent publication by C. Kushida et al.
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Kushida CA, Roth T, Shapiro CM, Roy A, Rosenberg R, Ajayi AO, Seiden D, and Gudeman J
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- Humans, Polysomnography, Narcolepsy drug therapy, Sodium Oxybate therapeutic use
- Published
- 2022
- Full Text
- View/download PDF
40. Is the sodium in sodium oxybate a risk for heart health? A plain language summary of publication.
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Avidan AY and Kushida CA
- Subjects
- Humans, Language, Sodium, Narcolepsy diagnosis, Sodium Oxybate adverse effects
- Abstract
What Is This Summary About?: Sodium oxybate is a medicine for narcolepsy symptoms. It contains a high level of sodium. Should people taking sodium oxybate and their doctors worry about the sodium increasing their risk of heart or cardiovascular problems? This is a summary of an article that reviewed 20 years of published data to answer that question., What Were the Results?: We found that sodium oxybate was not linked to cardiovascular risks, such as heart attacks or strokes., What Do the Results Mean?: This suggests that the sodium in sodium oxybate may not add cardiovascular risk for people with narcolepsy. People currently taking sodium oxybate should talk to their doctor to ask if they need to be concerned about the sodium in their medicine. People who take sodium oxybate are unlikely to need to change their sodium oxybate medicine because of the sodium.
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- 2022
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41. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance.
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Tu AY, Crawford MR, Dawson SC, Fogg LF, Turner AD, Wyatt JK, Crisostomo MI, Chhangani BS, Kushida CA, Edinger JD, Abbott SM, Malkani RG, Attarian HP, Zee PC, and Ong JC
- Subjects
- Humans, Polysomnography, Sleep, Treatment Outcome, Cognitive Behavioral Therapy, Sleep Apnea, Obstructive complications, Sleep Apnea, Obstructive epidemiology, Sleep Apnea, Obstructive therapy, Sleep Initiation and Maintenance Disorders complications, Sleep Initiation and Maintenance Disorders epidemiology, Sleep Initiation and Maintenance Disorders therapy
- Abstract
Study Objectives: This study examines the impact of cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) therapy for comorbid insomnia and sleep apnea on nocturnal sleep and daytime functioning., Methods: A partial factorial design was used to examine treatment pathways with CBT-I and PAP and the relative benefits of each treatment. One hundred eighteen individuals with comorbid insomnia and sleep apnea were randomized to receive CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only. Participants were assessed at baseline, PAP titration, and 30 and 90 days after PAP initiation. Outcome measures included sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and cognitive emotional measures., Results: A main effect of time was found on diary-measured sleep parameters (decreased sleep onset latency and wake after sleep onset; increased total sleep time and sleep efficiency) and actigraphy-measured sleep parameters (decreased wake after sleep onset; increased sleep efficiency) and daytime functioning (reduced Epworth Sleepiness Scale, Flinders Fatigue Scale; increased Functional Outcome of Sleep Questionnaire) across all arms (all P < .05). Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured sleep onset latency and wake after sleep onset and increasing sleep efficiency, as well as improving Functional Outcome of Sleep Questionnaire and Flinders Fatigue Scale compared to self-monitoring., Conclusions: Improvements in sleep and daytime functioning were found with PAP alone or concomitant with CBT-I. However, more rapid effects were observed on self-reported sleep and daytime performance when receiving CBT-I regardless of when it was initiated. Therefore, concomitant treatment appears to be a favorable approach to accelerate treatment outcomes., Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS); URL: https://clinicaltrials.gov/ct2/show/NCT01785303; Identifier: NCT01785303., Citation: Tu AY, Crawford MR, Dawson SC, et al. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med . 2022;18(3):789-800., (© 2022 American Academy of Sleep Medicine.)
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- 2022
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42. Important advances in sleep research in 2021.
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West LC and Kushida CA
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- Humans, Sleep, Sleep Wake Disorders therapy
- Abstract
Competing Interests: CAK reports personal fees related to consultancies or participation in medical advisory boards from XW Pharma, Idorsia, Merck, Jazz Pharmaceuticals, Avadel Pharmaceuticals, Cerebra, and VIVOS; grants or contracts with the National Institutes of Health, Avadel Pharmaceuticals, AmCad BioMed Corporation, Jazz Pharmaceuticals, Merck Sharp & Dohme, Parexel International Corporation, Asate, Inspire Medical Systems, and Respironics; lecture honoraria from ResMed Asia and Itamar Medical; and stock or stock options from M3 Public Benefit Corporation, Restful Robotics, VIVOS, and Koko. LCW declares no competing interests.
- Published
- 2022
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43. Estimation of Apnea-Hypopnea Index Using Deep Learning On 3-D Craniofacial Scans.
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Hanif U, Leary E, Schneider L, Paulsen R, Morse AM, Blackman A, Schweitzer P, Kushida CA, Liu S, Jennum P, Sorensen H, and Mignot E
- Subjects
- Canada, Humans, Polysomnography, Deep Learning, Sleep Apnea Syndromes diagnostic imaging, Sleep Apnea, Obstructive diagnostic imaging
- Abstract
Obstructive sleep apnea (OSA) is characterized by decreased breathing events that occur through the night, with severity reported as the apnea-hypopnea index (AHI), which is associated with certain craniofacial features. In this study, we used data from 1366 patients collected as part of Stanford Technology Analytics and Genomics in Sleep (STAGES) across 11 US and Canadian sleep clinics and analyzed 3D craniofacial scans with the goal of predicting AHI, as measured using gold standard nocturnal polysomnography (PSG). First, the algorithm detects pre-specified landmarks on mesh objects and aligns scans in 3D space. Subsequently, 2D images and depth maps are generated by rendering and rotating scans by 45-degree increments. Resulting images were stacked as channels and used as input to multi-view convolutional neural networks, which were trained and validated in a supervised manner to predict AHI values derived from PSGs. The proposed model achieved a mean absolute error of 11.38 events/hour, a Pearson correlation coefficient of 0.4, and accuracy for predicting OSA of 67% using 10-fold cross-validation. The model improved further by adding patient demographics and variables from questionnaires. We also show that the model performed at the level of three sleep medicine specialists, who used clinical experience to predict AHI based on 3D scan displays. Finally, we created topographic displays of the most important facial features used by the model to predict AHI, showing importance of the neck and chin area. The proposed algorithm has potential to serve as an inexpensive and efficient screening tool for individuals with suspected OSA.
- Published
- 2021
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44. Basal Ganglia Local Field Potentials as a Potential Biomarker for Sleep Disturbance in Parkinson's Disease.
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Baumgartner AJ, Kushida CA, Summers MO, Kern DS, Abosch A, and Thompson JA
- Abstract
Sleep disturbances, specifically decreases in total sleep time and sleep efficiency as well as increased sleep onset latency and wakefulness after sleep onset, are highly prevalent in patients with Parkinson's disease (PD). Impairment of sleep significantly and adversely impacts several comorbidities in this patient population, including cognition, mood, and quality of life. Sleep disturbances and other non-motor symptoms of PD have come to the fore as the effectiveness of advanced therapies such as deep brain stimulation (DBS) optimally manage the motor symptoms. Although some studies have suggested that DBS provides benefit for sleep disturbances in PD, the mechanisms by which this might occur, as well as the optimal stimulation parameters for treating sleep dysfunction, remain unknown. In patients treated with DBS, electrophysiologic recording from the stimulating electrode, in the form of local field potentials (LFPs), has led to the identification of several findings associated with both motor and non-motor symptoms including sleep. For example, beta frequency (13-30 Hz) oscillations are associated with worsened bradykinesia while awake and decrease during non-rapid eye movement sleep. LFP investigation of sleep has largely focused on the subthalamic nucleus (STN), though corresponding oscillatory activity has been found in the globus pallidus internus (GPi) and thalamus as well. LFPs are increasingly being recognized as a potential biomarker for sleep states in PD, which may allow for closed-loop optimization of DBS parameters to treat sleep disturbances in this population. In this review, we discuss the relationship between LFP oscillations in STN and the sleep architecture of PD patients, current trends in utilizing DBS to treat sleep disturbance, and future directions for research. In particular, we highlight the capability of novel technologies to capture and record LFP data in vivo , while patients continue therapeutic stimulation for motor symptoms. These technological advances may soon allow for real-time adaptive stimulation to treat sleep disturbances., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Baumgartner, Kushida, Summers, Kern, Abosch and Thompson.)
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- 2021
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45. Objective adherence to dental device versus positive airway pressure treatment in adults with obstructive sleep apnea.
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Xu L, Xie D, Griffin KS, Staley B, Wang Y, Nichols DA, Benca RM, Pack AI, Redline S, Walsh JK, Kushida CA, and Kuna ST
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- Female, Humans, Male, Middle Aged, Occlusal Splints, Treatment Outcome, Continuous Positive Airway Pressure, Mandibular Advancement, Patient Compliance, Sleep Apnea, Obstructive therapy
- Abstract
Although mandibular advancement device (MAD) treatment of adults with obstructive sleep apnea (OSA) is generally less efficacious than positive airway pressure (PAP), the two treatments are associated, with similar clinical outcomes. As a sub-analysis of a randomized trial comparing the effect of MAD versus PAP on blood pressure, this study compared objectively measured adherence to MAD versus PAP treatment in adults with OSA. Adults with OSA (age 54.1 ± 11.2 [standard deviation] years, 71.1% male, apnea-hypopnea index 31.6 ± 22.7 events/h) were randomized to MAD (n = 89) or PAP (n = 91) treatment for 3-6 months. Objective adherence was assessed with a thermal sensor embedded in the MAD and a pressure sensor in the PAP unit. In a per protocol analysis, no difference was observed in average daily hours of use over all days in participants on MAD (n = 35, 4.4 ± 2.9 h) versus PAP (n = 51, 4.7 ± 1.6 h, p = .597) treatment when days with missing adherence data were included as no use. MAD was used on a lower percentage of days (62.5 ± 36.4% versus 79.9 ± 19.8%, p = .047), but with greater average daily hours of use on days used (6.4 ± 1.9 h versus 5.7 ± 1.2 h, p = .013). Average daily hours of use in the first week were associated with long-term adherence to MAD (p < .0001) and PAP (p = .0009) treatment. Similar results were obtained when excluding days with missing adherence data. In conclusion, no significant difference was observed in objectively measured average daily hours of MAD and PAP adherence in adults with OSA, despite differences in the patterns of use. MAD adherence in the first week predicted long-term use., (© 2020 European Sleep Research Society.)
- Published
- 2021
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46. The sodium in sodium oxybate: is there cause for concern?
- Author
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Avidan AY and Kushida CA
- Subjects
- Humans, Sodium, Cataplexy, Disorders of Excessive Somnolence, Narcolepsy drug therapy, Sodium Oxybate adverse effects
- Abstract
Sodium oxybate (SO), the sodium salt of γ-hydroxybutyric acid, is one of the primary pharmacologic agents used to treat excessive sleepiness, disturbed nighttime sleep, and cataplexy in narcolepsy. The sodium content of SO ranges from 550 to 1640 mg at 3-9 g, given in two equal nightly doses. Clinicians are advised to consider daily sodium intake in patients with narcolepsy who are treated with SO and have comorbid disorders associated with increased cardiovascular (CV) risk, in whom sodium intake may be a concern. It remains unclear whether all patients with narcolepsy treated with SO should modify or restrict their sodium intake. No data are currently available specific to the sodium content or threshold of SO at which patients might experience increased CV risk. To appraise attributable risk, critical evaluation of the literature was conducted to examine the relationship between CV risk and sodium intake, narcolepsy, and SO exposure. The findings suggest that increased CV risk is associated with extremes of daily sodium intake, and that narcolepsy is associated with comorbidities that may increase CV risk in some patients. However, data from studies regarding SO use in patients with narcolepsy have shown a very low frequency of CV side effects (eg, hypertension) and no overall association with CV risk. In the absence of data that specifically address CV risk with SO based on its sodium content, the clinical evidence to date suggests that SO treatment does not confer additional CV risk in patients with narcolepsy., (Copyright © 2020 Elsevier B.V. All rights reserved.)
- Published
- 2020
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47. A randomized controlled trial of CBT-I and PAP for obstructive sleep apnea and comorbid insomnia: main outcomes from the MATRICS study.
- Author
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Ong JC, Crawford MR, Dawson SC, Fogg LF, Turner AD, Wyatt JK, Crisostomo MI, Chhangani BS, Kushida CA, Edinger JD, Abbott SM, Malkani RG, Attarian HP, and Zee PC
- Subjects
- Adult, Humans, Outcome Assessment, Health Care, Treatment Outcome, Cognitive Behavioral Therapy, Sleep Apnea, Obstructive epidemiology, Sleep Apnea, Obstructive therapy, Sleep Initiation and Maintenance Disorders epidemiology, Sleep Initiation and Maintenance Disorders therapy
- Abstract
Study Objectives: To investigate treatment models using cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) for people with obstructive sleep apnea (OSA) and comorbid insomnia., Methods: 121 adults with OSA and comorbid insomnia were randomized to receive CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only. PAP was delivered following standard clinical procedures for in-lab titration and home setup and CBT-I was delivered in four individual sessions. The primary outcome measure was PAP adherence across the first 90 days, with regular PAP use (≥4 h on ≥70% of nights during a 30-day period) serving as the clinical endpoint. The secondary outcome measures were the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI <5), remission (ISI <8), and response (ISI reduction from baseline >7) serving as the clinical endpoints., Results: No significant differences were found between the concomitant treatment arms and PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint. Compared to PAP alone, the concomitant treatment arms reported a significantly greater reduction from baseline on the ISI (p = .0009) and had a greater percentage of participants who were good sleepers (p = .044) and remitters (p = .008). No significant differences were found between the sequential and concurrent treatment models on any outcome measure., Conclusions: The findings from this study indicate that combining CBT-I with PAP is superior to PAP alone on insomnia outcomes but does not significantly improve adherence to PAP., (© Sleep Research Society 2020. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.)
- Published
- 2020
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48. How Support of Early Career Researchers Can Reset Science in the Post-COVID19 World.
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Gibson EM, Bennett FC, Gillespie SM, Güler AD, Gutmann DH, Halpern CH, Kucenas SC, Kushida CA, Lemieux M, Liddelow S, Macauley SL, Li Q, Quinn MA, Roberts LW, Saligrama N, Taylor KR, Venkatesh HS, Yalçın B, and Zuchero JB
- Subjects
- Achievement, Biomedical Research, Humans, Research Personnel education, Science education, Science trends, Universities, Career Mobility, Research trends, Research Personnel trends
- Abstract
The COVID19 crisis has magnified the issues plaguing academic science, but it has also provided the scientific establishment with an unprecedented opportunity to reset. Shoring up the foundation of academic science will require a concerted effort between funding agencies, universities, and the public to rethink how we support scientists, with a special emphasis on early career researchers., Competing Interests: Declaration of Interests Dr. Roberts serves as Editor-in-Chief of books for the American Psychiatric Association Publishing Division and as Editor-in-Chief of the journal Academic Medicine. Unrelated to this publication, Dr. Roberts serves as an advisor for the Bucksbaum Institute of the University of Chicago Pritzker School of Medicine and owns the small business Terra Nova Learning Systems., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2020
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49. A Multidisciplinary Perioperative Intervention to Improve Positive Airway Pressure Adherence in Patients With Obstructive Sleep Apnea: A Case Series.
- Author
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Wong JK, Rodriguez EM, Wee-Tom B, Lejano M, Kushida CA, Howard SK, Memtsoudis SG, and Mariano ER
- Subjects
- Aged, Humans, Male, Middle Aged, Patient Care Team, Patient Compliance, Perioperative Care, Continuous Positive Airway Pressure methods, Sleep Apnea, Obstructive therapy
- Abstract
Positive airway pressure (PAP) adherence in patients with obstructive sleep apnea (OSA) remains low despite known benefits. The postoperative inpatient period may represent a unique opportunity to address technical issues and promote self-efficacy, 2 important factors determining adherence, which may result in patients' seeking outpatient sleep medicine follow-up. We report our experience in developing a perioperative multidisciplinary intervention of reintroducing PAP therapy to nonadherent OSA patients with the intent of motivating patients to return to their outpatient sleep medicine clinics.
- Published
- 2020
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50. Positive Airway Pressure and Survival in Patients With Obstructive Sleep Apnea.
- Author
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Kushida CA
- Subjects
- Humans, Obesity, Polysomnography, Sleep Apnea, Obstructive
- Published
- 2019
- Full Text
- View/download PDF
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