Search

STUDY OBJECTIVES: Excessive daytime sleepiness associated with obstructive sleep apnea affects 9%–22% of continuous positive airway pressure–treated patients. An indirect treatment comparison meta-analysis was performed to compare efficacy and safety of medications (solriamfetol, modafinil, and armodafinil) approved to treat excessive daytime sleepiness associated with obstructive sleep apnea. METHODS: Efficacy and safety measures assessed in this indirect treatment comparison included Epworth Sleepiness Scale (ESS), 20-minute Maintenance of Wakefulness Test (MWT20), Clinical Global Impression of Change (CGI-C), Functional Outcomes of Sleep Questionnaire (FOSQ), and incidence of treatment-emergent adverse events (any, serious, or leading to discontinuation). RESULTS: A systematic literature review identified 6 parallel-arm, placebo-controlled randomized controlled trials that randomized 1,714 total participants to placebo, solriamfetol, modafinil, or armodafinil. In this indirect treatment comparison, all comparators were associated with greater improvements than placebo on the ESS, MWT20, and CGI-C after 4, 8, and 12 weeks of treatment. Relative to comparators and placebo at 12 weeks, solriamfetol at 150 mg or 300 mg had the highest probabilities of improvement in the ESS, MWT20, and CGI-C. Modafinil (200 or 400 mg) and solriamfetol (150 or 300 mg) were associated with greater improvement on the FOSQ than placebo at 12 weeks. Less than 2% of patients using placebo or comparators experienced serious or discontinuation-related treatment-emergent adverse events. CONCLUSIONS: The results of this indirect treatment comparison show 12 weeks of treatment with solriamfetol, modafinil, and armodafinil resulted in varying levels of improvement on the ESS, MWT20, and CGI-C and similar safety risks in participants with excessive daytime sleepiness associated with obstructive sleep apnea. CITATION: Ronnebaum S, Bron M, Patel D, et al. Indirect treatment comparison of solriamfetol, modafinil, and armodafinil for excessive daytime sleepiness in obstructive sleep apnea. J Clin Sleep Med. 2021;17(12):2543–2555.

BackgroundEvaluation 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). MethodsUsing 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. ResultsThe 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. ConclusionThis 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.

Introduction Mild obstructive sleep apnea (OSA) is increasingly common in the VA. The first-line therapies are medical devices worn each night while asleep to control or manage OSA. These devices are burdensome for our patients with mild OSA. Stronger oral musculature can help reduce mild OSA. A new transoral Neuromuscular Electrical Stimulation (NMES) device was recently approved by the US FDA called eXciteOSA (Signifier Medical Technologies, Needham, MA). The eXciteOSA device provides gentle, low-frequency electrical stimulation intraorally to the tongue muscle and is efficacious for mild OSA. Methods A retrospective review of the data of the 71 patients prescribed the eXciteOSA device at the VA San Diego was analyzed. The device is prescribed for use over two phases: (1) one 20-minute session per day over 42 consecutive days and then (2) one 20-minute session on two days out of each week. Respiratory therapists performed 1-2 phone call visits to assess symptoms and address device concerns. Results 68 of the 71 patients used the device for at least one 20-minute session over the first 42 days. Three patients (4.2%) did not use the device. Adherence was 60% for all 71 patients and 63% for the 68 patients who used it at least once. This means that, on average, our Veteran patients completed one 20-minute session on 25 of the first 42 days. Conclusion Recent non-Veteran data showed an adherence rate of ~80% (percentage of days with one completed 20-minute session over the first 42 days). Our analysis found an adherence rate of ~60%, suggesting significant room for improvement in eXciteOSA device use in Veterans. Future adherence studies should look at methods to improve device use over the first 42 days. In addition, more research may be needed to understand better what amount of use is efficacious on an individual basis. Some patients may obtain an adequate response with fewer sessions, while others may need more. It is unknown which endotypes of OSA most benefit from NMES, but further research is ongoing. Support (if any) VA RR&D D2651-R and the Sleep Medicine Section of the VA San Diego Healthcare System supported this project.

Introduction The Veterans Health Administration (VA) is one of the largest integrated healthcare systems in the United States. Key risk factors for obstructive sleep apnea (OSA) include aging, weight, and male gender, all of which are highly prevalent in the VA population and help to explain the higher rates of OSA in the VA. The Pulmonary Sleep Program at the VA San Diego Healthcare System (VASDHS) started a patient database over twenty years ago for its home sleep apnea testing (HSAT) program. An analysis of ten years of diagnostic HSAT data was reported on over 12,500 patients in 2014. This analysis focuses on an update on the last four years and a comparison to 2014. Methods A retrospective review of the local clinical database of HSAT diagnostic testing was conducted. The database contained 8,928 sleep studies from 2018 to 2022. Invalid studies were removed. Only initial diagnostic studies were included. Results Of the 8,928 diagnostic studies, 2,564 tested negative for OSA (28.7%). Of the 6,364 positive cases, 43.3% were mild, 28.8% were moderate, and 27.9% were severe. The percentages of each OSA severity level were stable across these years (mild: 42%-45%; moderate: 27%-32%; and severe: 26%-29%). The mean AHI did not significantly change from 2018 (24.1+/-20.6) to 2022 (25.1+/-21.2) (overall mean 24.4+/-20.3; range: 5-140). Conclusion Based on this extensive retrospective review of diagnostic testing at a single, high-volume HSAT program, it appears that OSA severity levels have stabilized over these past five years, with the highest percentage of mild OSA cases (~43%) followed by moderate (~29%) and severe (~28%). Our facility saw a significant decrease in severe cases (60% to 30%) and increase in mild OSA (7% to 35%) from 2004 to 2013. Today, over 4 out of every 10 new OSA diagnoses are mild, which has significant treatment implications given that adherence to the two primary medical device options is suboptimal. Identifying patient-centered treatment options for these patients is a priority. Support (if any) VA RR&D D2651-R and the Sleep Medicine Section of the VA San Diego Healthcare System supported this project.

In recent years, sleep-disordered breathing (SDB) has been recognized as a prevalent but under-diagnosed condition in adults and has prompted the need for new and better diagnostic and therapeutic options. To facilitate the development and availability of innovative, safe and effective SDB medical device technologies for patients in the United States, the US Food and Drug Administration collaborated with six SDB-related professional societies and a consumer advocacy organization to convene a public workshop focused on clinical investigations of SDB devices. Sleep medicine experts discussed appropriate definitions of terms used in the diagnosis and treatment of SDB, the use of home sleep testing versus polysomnography, clinical trial design issues in studying SDB devices, and current and future trends in digital health technologies for diagnosis and monitoring SDB. The panel’s breadth of clinical expertise and experience across medical specialties provided useful and important insights regarding clinical trial designs for SDB devices. CITATION: Mann EA, Nandkumar S, Addy N, et al. Study design considerations for sleep-disordered breathing devices. J Clin Sleep Med. 2020;16(3):441–449.

Introduction: Few studies have asked chronic obstructive pulmonary disease (COPD) -obstructive sleep apnea (OSA) overlap syndrome patients what outcomes of continuous positive airway pressure (CPAP) therapy are important to them, while also considering their self-reported CPAP adherence barriers and facilitators. This study conducted a series of focus groups to learn about those issues with the goal of applying these findings to the design of a larger Patient-Centered Outcomes Research Institute-funded scientific study, the O(2)VERLAP Study. Methods: People previously diagnosed with both COPD and OSA, who were current or recent past users of the standard therapy for each condition (i.e., supplemental oxygen and CPAP, respectively), were included. Three qualitative focus groups were run using different communication modalities: (1) teleconference (audio only), (2) in-person, and (3) web-based. Results: The focus groups included a total of 17 participants. The telephone and online focus groups resulted in more relevant and content-rich transcripts, while the in-person focus groups had far fewer excerpts able to be coded. Participants were most concerned about mask fit and comfort. Other key factors affecting CPAP use included nasal dryness and issues concerning insurance. The most important outcome to patients was daytime functioning. Discussion: This work found that telephone and web-based qualitative focus groups resulted in greater topical discussions than in-person focus groups, likely due to the customary socializing that occurs in-person. The study identified: (1) CPAP use barriers and facilitators that helped guide intervention development for the larger study and, (2) daytime functioning as the most important outcome for patients.

STUDY OBJECTIVES: (1) Review the prevalence and comorbidity of sleep disorders among United States military personnel and veterans. (2) Describe the status of sleep care services at Veterans Health Administration (VHA) facilities. (3) Characterize the demand for sleep care among veterans and the availability of sleep care across the VHA. (4) Describe the VA TeleSleep Program that was developed to address this demand. METHODS: PubMed and Medline databases (National Center for Biotechnology Information, United States National Library of Medicine) were searched for terms related to sleep disorders and sleep care in United States military and veteran populations. Information related to the status of sleep care services at VHA facilities was provided by clinical staff members at each location. Additional data were obtained from the VA Corporate Data Warehouse. RESULTS: Among United States military personnel, medical encounters for insomnia increased 372% between 2005–2014; encounters for obstructive sleep apnea (OSA) increased 517% during the same period. The age-adjusted prevalence of sleep disorder diagnoses among veterans increased nearly 6-fold between 2000–2010; the prevalence of OSA more than doubled in this population from 2005–2014. CONCLUSIONS: Most VA sleep programs are understaffed for their workload and have lengthy wait times for appointments. The VA Office of Rural Health determined that the dilemma of limited VHA sleep health care availability and accessibility might be solved, at least in part, by implementing a comprehensive telehealth program in VA medical facilities. The VA TeleSleep Program is an expansion of telemedicine services to address this need, especially for veterans in rural or remote regions. CITATION: Sarmiento KF, Folmer RL, Stepnowsky CJ, Whooley MA, Boudreau EA, Kuna ST, Atwood CW, Smith CJ, Yarbrough WC. National expansion of sleep telemedicine for veterans: the telesleep program. J Clin Sleep Med. 2019;15(9):1355–1364.

Introduction Nonadherence to positive airway pressure (PAP) therapy is common in comorbid insomnia and obstructive sleep apnea (COMISA). We previously reported a novel behavioral treatment for COMISA which improves both PAP adherence and sleep. Our current goal was to assess whether improvements in PAP self-efficacy, knowledge, and decisional balance (targets of treatment) are associated with improvements in PAP use and sleep quality. We also collected participants’ perceptions of benefits and challenges of PAP during intervention. Methods 125 veterans (96% men, 39% non-Hispanic white, 24% Black, 17% Hispanic/Latino) with COMISA were randomized to a 5-week intervention integrating behavioral insomnia therapy with a PAP adherence program versus general sleep education (control). Objective PAP use data and Pittsburgh Sleep Quality Index (PSQI) were collected over 6 months. Three behavior change subscales (PAP Self-Efficacy [PAP-SE], Decisional Balance Index [DBI], Knowledge [KNOW]) were administered at 6-months. Weekly self-report of participant-perceived benefits and challenges of PAP use were collected among intervention participants. Subscale scores, PAP use and PSQI were compared between intervention and control, and associations were tested. Change in mean number of benefits and challenges of PAP use were also tested (all analyses intent-to-treat). Results At 6-months, compared to controls, intervention participants had higher scores on all three subscales: PAP-SE (4.1 intervention versus 3.5 control, respectively), DBI (8.3, 0.9) and KNOW (10.5, 9.6, all p Conclusion Behavioral treatment for COMISA improves behavioral determinants of PAP use, which is associated with improvements in PAP use and sleep quality. In addition, with treatment, perceived benefits of PAP increase and challenges decrease. These findings suggest improvements in self-efficacy, knowledge and perceived benefits of PAP are important mechanisms through which behavioral interventions improve PAP use in older adults with COMISA. Support (If Any) VAHSRD (IIR12–353-Alessi, RCSA20-191-Martin) and NIH (NHLBI K24HL143055-Martin, NIA K23AG049955-Dzierzewski)

Introduction The CPAP recall of 2021 has highlighted an inherent problem that occurs when a field of medicine is overly dependent on a single class of medical devices to treat a condition. The global shortage of CPAP devices has led to numerous individuals with OSA being unable to obtain a CPAP machine to treat their condition, including those with severe OSA. CPAP is well known to be efficacious in treating OSA, but has limited effectiveness, particularly for mild-to-moderate cases. It has been reported that there are nearly 200 different medical devices approved by the FDA to treat OSA. The goal of this project was to search the FDA databases to investigate the number of devices currently on file with the FDA. A secondary goal was to examine the range of FDA product categories for the treatment of OSA. Methods An FDA database (AccessGUDID; https://accessgudid.nlm.nih.gov) with a release date of December 1, 2021 was searched for devices that are approved for the treatment of sleep apnea. The text string “sleep apnea” was used for the search. Diagnostic devices, duplicate versions of the same treatment devices, and device accessories were excluded from the total counts. The FDA classifies medical devices into three categories (I, II, III), with a higher classification level indicating greater risk to patients. Results The FDA AccessGUDID database search returned 166 results, which resulted in 72 unique devices across 10 product code categories. 9 of the 10 product codes in the FDA database were class II (medium risk) and 1/10 was classified as III (high risk). 65 of the devices were reported to be in commercial distribution at the time of the search and 7 were not. Conclusion This analysis found that a relatively large number of FDA-approved devices exist for the treatment of OSA across a range of product categories. The field is encouraged to develop a better understanding of which subgroups of OSA patients could benefit from alternative forms of treatment in an effort to diversify treatment options and reduce the field’s reliance on a single type of device, particularly for patients with mild-to-moderate OSA. Support (If Any) VA IIR 16-277

Conducting biomedical research using smartphones is a novel approach to studying health and disease that is only beginning to be meaningfully explored. Gathering large-scale, real-world data to track disease manifestation and long-term trajectory in this manner is quite practical and largely untapped. Researchers can assess large study cohorts using surveys and sensor-based activities that can be interspersed with participants’ daily routines. In addition, this approach offers a medium for researchers to collect contextual and environmental data via device-based sensors, data aggregator frameworks, and connected wearable devices. The main aim of the SleepHealth Mobile App Study (SHMAS) was to gain a better understanding of the relationship between sleep habits and daytime functioning utilizing a novel digital health approach. Secondary goals included assessing the feasibility of a fully-remote approach to obtaining clinical characteristics of participants, evaluating data validity, and examining user retention patterns and data-sharing preferences. Here, we provide a description of data collected from 7,250 participants living in the United States who chose to share their data broadly with the study team and qualified researchers worldwide., Measurement(s) Demographic Data • Alcohol Consumption • Smoking Behavior • Socioeconomic Factors • Personal Medical History • Sleepiness • Sleep Quality • Objective Alertness Technology Type(s) Survey • Epworth Sleepiness Scale Questionnaire • Pittsburgh Sleep Quality Index • Psychomotor Vigilance Task 3-Minute Version (PVT-B) Sample Characteristic - Organism Homo sapiens Sample Characteristic - Location United States of America Machine-accessible metadata file describing the reported data: 10.6084/m9.figshare.12647108

Study Objective Obstructive sleep apnea (OSA) is a highly prevalent yet underdiagnosed disorder affecting US military Veterans. The Remote Veterans Apnea Management Platform (REVAMP) is a web-based OSA management program created to improve access to care. REVAMP was launched within the Veterans Health Administration (VHA) in July 2017, with variable patient recruitment rates (from 0 to 573 patients per site) at the first 10 Veterans Affairs (VA) medical centers (Wave-1 sites). This study aimed to examine the contextual circumstances surrounding the implementation of REVAMP from the provider perspective to inform strategies to increase its uptake at future rollout sites. Methods A purposive sample of REVAMP site leaders from the Wave-1 sites was recruited with additional staff members being solicited as well. Semi-structured interviews were conducted. Two independent coders reviewed individual transcripts using content analysis to identify emerging themes. Results Fifteen individuals from Wave-1 sites were interviewed. Implementation of REVAMP was facilitated by the presence of leadership support, staff, and time dedicated to REVAMP, and perceived usefulness of REVAMP by staff as well as positive feedback from the Veterans using REVAMP. The difficulty of supporting Veteran creation of login credentials to the program and integrating REVAMP into the existing workflow were major barriers to its implementation. Conclusion Improving leadership engagement, simplifying the enrollment process, and enhancing the medical staff experience through shared best practice alerts were identified as actions needed to improve the penetration of REVAMP at future rollout sites.

Study ObjectivesCognitive behavioral therapy for insomnia (CBTI) for comorbid insomnia and obstructive sleep apnea (OSA) has had mixed results. We integrated CBTI with a positive airway pressure (PAP) adherence program and tested effects on sleep and PAP use.Methods125 veterans (mean age 63.2, 96% men, 39% non-Hispanic white, 26% black/African American, 18% Hispanic/Latino) with comorbid insomnia and newly-diagnosed OSA (apnea-hypopnea index ≥ 15) were randomized to 5-weekly sessions integrating CBTI with a PAP adherence program provided by a “sleep coach” (with behavioral sleep medicine supervision), or 5-weekly sleep education control sessions. Participants and assessment staff were blinded to group assignment. Outcomes (baseline, 3 and 6 months) included Pittsburgh Sleep Quality Index (PSQI), 7-day sleep diary (sleep onset latency [SOL-D], wake after sleep onset [WASO-D], sleep efficiency [SE-D]), 7-day actigraphy (SE-A), and objective PAP use (hours/night and nights ≥ 4 h). Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) were also collected.ResultsCompared to controls, intervention participants showed greater improvement (baseline to 3 and 6 months, respectively) in PSQI (−3.2 and −1.7), SOL-D (−16.2 and −15.5 minutes), SE-D (10.5% and 8.5%), SE-A (4.4% and 2.6%) and more 90-day PAP use (1.3 and 0.9 more hours/night, 17.4 and 11.3 more nights PAP ≥ 4 h). 90-day PAP use at 3 months was 3.2 and 1.9 h/night in intervention versus controls. Intervention participants also had greater improvements in ISI, ESS, and FOSQ-10 (all p < 0.05).ConclusionsAn intervention integrating CBTI with a PAP adherence program delivered by a supervised sleep coach improved sleep and PAP use in adults with comorbid insomnia and OSA.Trial RegistrationClinicalTrials.govStudy name: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older VeteransURL: https://clinicaltrials.gov/ct2/results?cond=&term=NCT02027558&cntry=&state=&city=&dist=Registration: NCT02027558

Introduction The Psychomotor Vigilance Test is a well-validated measure of sustained attention used to assess daytime alertness in sleep research studies.1 It is commonly used in a variety of research settings due to its high sensitivity to sleep loss and absence of learning effects,2 making it an ideal tool to assess objective alertness. As some types of sleep research transition out of controlled laboratory environments, tools like the PVT require modification to maximize their reliability. The validation of the 3-minute version (PVT-B) against the 10-minute PVT is an example of this modification.3 However, considerable work is needed to improve trust in the utility of the PVT-B in and outside of traditional laboratory settings. Methods We carefully analyzed data from a mobile-based version of the PVT-B, noting responses that occurred during the interstimulus interval which were termed “wrong taps.” Wrong taps indicated that participants were not performing the task as instructed. In some cases, wrong taps occurred across multiple trials of the same PVT block, indicative of participants repeatedly tapping the screen throughout the task to minimize response times. A comprehensive examination of wrong taps was carried out in order to identify instances where this pattern emerged. Results A total of 1,338,538 PVT-B trials from 7,028 participants were examined to determine the number of wrong taps present across all trials. While 91.7% of PVT-B trials were free of wrong taps, 8.3% of PVT-B trials contained 1 or more wrong taps and 5.2% contained 2 or more wrong taps. It appears that a maximum of one wrong tap per trial is acceptable and trials containing 2 or more should be excluded to maximize PVT data quality. Conclusion Utilizing a metric like wrong taps can help identify individuals taking the PVT-B who are tapping the screen multiple times prior to stimulus display. Closely examining this metric can help to ensure the validity of PVT-B administrations. Two possible uses of the metric could be to provide feedback during training trials and to remove trials where this strategy was employed. Support (if any) This analysis was supported by the VA San Diego Healthcare System Research Service.

Introduction CPAP is intended for use during sleep to alleviate disordered breathing. Most patients who use CPAP do so for only a portion of their sleep period, although anecdotally it is known that some also use CPAP while awake. We compared the unusually high levels of CPAP adherence found in a recent study of patients with Overlap Syndrome to a VA clinical population and to participants from the APPLES study. Methods CPAP adherence levels were taken from three sources: (1) The O2VERLAP Study, a large comparative effectiveness trial that used two different methods of providing information and support to current CPAP users diagnosed with both OSA and COPD. (2) Combined data from the four most recent clinical CPAP trials conducted at VA San Diego Healthcare System. (3) The APPLES study. Total sample sizes were 332, 957, and 405, respectively. Total sleep time (TST) and total sleep period (TSP) were assessed via the Pittsburgh Sleep Quality Index (PSQI) for (1) and (2) and via polysomnography for (3). Results Mean CPAP use, TST, and TSP for each source were: (1) 6.7, 6.8, & 8.1; (2) 4.0, 6.1, & 7.5; (3) 4.5, 6.6, & 8.0. We examined the ratios of adherence over either TST or TSP, and the ratios for each source were: (1) 98% & 83%; (2) 66% & 55%; (3) 68% & 56%. Conclusion This comparison demonstrates that unlike many CPAP users who tend to use therapy for only a fraction of time spent asleep, patients with COPD and OSA exhibit higher levels of adherence which often exceed sleep time and may be obtaining additional benefits from CPAP use during non-sleep periods. More research is needed both to improve CPAP delivery and support for patients who are using CPAP sub optimally and to understand the factors that account for the heightened levels of CPAP adherence in COPD. Support PPRND #1507-31666; IIR 02-275; IIR 07-163; IIR 12-069; PULM-028-12F.

Introduction CPAP therapy is prescribed to help manage disordered breathing during sleep time periods. Most users, especially those with non-severe obstructive sleep apnea (OSA), use it only for some portion of their sleep period. Patients with Overlap Syndrome have both OSA and chronic obstructive pulmonary disease (COPD). While there has been some research on CPAP use levels in this patient population, there has been little indication that they use CPAP any differently than those with OSA only. Methods The O2VERLAP Study was a large comparative effectiveness trial enrolling people with COPD and OSA and using two different methods of providing information and support to current users of CPAP therapy. The study utilized an electronic national recruitment strategy and 332 participants were enrolled. CPAP data from the 12-week study period was analyzed. The Pittsburgh Sleep Quality Index was used to determine both estimated total sleep period (TSP) and total sleep time (TST). Because participants were all current users of CPAP, data from the total sample was combined and used. The percentage of TST and TSP that CPAP was used was calculated as CPAP use divided by either TST or TSP. Results The mean TST was 6.8 hours, TSP was 8.1 hours, and CPAP use was 6.7 hours. CPAP was used during 98.5% of the TST and during 82.7% of the TSP. Over 35% of the sample used CPAP at a level that was equal to or greater than their total sleep period. Conclusion Most OSA study populations use CPAP for some fraction of their night’s sleep. This COPD/OSA study population used CPAP to a markedly high level, including over one-third of the sample (n=~100) who used CPAP more than their self-reported sleep period. Further research on the extent and reasons for non-sleep period (i.e., daytime) CPAP use in COPD patients is warranted. Support PPRND #1507-31666.

Introduction Nocturia is common among patients with both insomnia disorder and obstructive sleep apnea (OSA) and adversely affects quality of life. Within a randomized controlled trial testing an integrated behavioral therapy for positive airway pressure (PAP) adherence and insomnia for patients with coexisting OSA and insomnia disorder, we examined the impact of the integrated therapy on nocturia frequency. Methods Patients aged > 50 years with untreated OSA (apnea hypopnea index > 15) and chronic insomnia disorder were recruited from a VA medical center and randomized to 5 weekly individual integrated behavioral treatment sessions versus control (general sleep education). Nocturia frequency (self-reported average number of nocturia events per night) was assessed at baseline, 3 months, and 6 months. Linear regression models were used to examine relationships between objective PAP adherence (# nights used > 4hrs over the last 30 days) and Insomnia Severity Index (ISI) score (0 [none] - 28 [severe]) and nocturia frequency (0 - 5+/night), and change in nocturia frequency associated with integrated therapy. Results Nocturia data were available for 112 participants (treatment=56, control=56; mean age 63 [SD 7], 95% male). Mean nocturia frequency (episodes/night) was 2.1 (SD 1.3; baseline), 1.6 (SD 1.1; 3 months), and 1.7 (SD 1.2; 6 months). Overall, higher PAP adherence (B=.029, p=.008) and ISI score improvement (B=0.05, p=.004) were associated with decreased nocturia frequency at 3-month follow-up. No differences were observed in nocturia frequency between treatment and control participants at baseline (p=.429). Integrated therapy reduced nocturia frequency at 3 months (B=-0.56, p=.020) but not at 6 months follow-up (B=-0.4, p=.081) compared to control. Conclusion Nocturia frequency improved with integrated behavioral therapy for PAP adherence and insomnia in veterans (primarily male) with co-existing OSA and insomnia. Additional studies are needed to examine the mechanisms underlying the relationship between the behavioral therapy for PAP adherence and insomnia and nocturia. Support VA HSR&D; NIA; VA GRECC

Digital technologies such as smartphones are transforming the way scientists conduct biomedical research. Several remotely conducted studies have recruited thousands of participants over a span of a few months allowing researchers to collect real-world data at scale and at a fraction of the cost of traditional research. Unfortunately, remote studies have been hampered by substantial participant attrition, calling into question the representativeness of the collected data including generalizability of outcomes. We report the findings regarding recruitment and retention from eight remote digital health studies conducted between 2014–2019 that provided individual-level study-app usage data from more than 100,000 participants completing nearly 3.5 million remote health evaluations over cumulative participation of 850,000 days. Median participant retention across eight studies varied widely from 2–26 days (median across all studies = 5.5 days). Survival analysis revealed several factors significantly associated with increase in participant retention time, including (i) referral by a clinician to the study (increase of 40 days in median retention time); (ii) compensation for participation (increase of 22 days, 1 study); (iii) having the clinical condition of interest in the study (increase of 7 days compared with controls); and (iv) older age (increase of 4 days). Additionally, four distinct patterns of daily app usage behavior were identified by unsupervised clustering, which were also associated with participant demographics. Most studies were not able to recruit a sample that was representative of the race/ethnicity or geographical diversity of the US. Together these findings can help inform recruitment and retention strategies to enable equitable participation of populations in future digital health research.

Introduction Research study recruitment has been profoundly affected by the COVID-19 pandemic, demonstrated by significant delays or pauses. Various guidelines pertaining to in-person visits have applied to research. Some call for exclusion of participants that the CDC has labeled “at increased risk”.1 For obstructive sleep apnea (OSA) studies, these guidelines have caused a sharp decrease in the number of new participants. This decrease is due to high rates of OSA comorbidities including obesity and diabetes. New evidence-based risk scores have been developed using individual- and community-level factors. The use of more refined COVID-19 risk scores can help protect patient safety while allowing research to continue. Methods The risk score assessment used for this study (COVID-19 Mortality Risk Calculator; Johns Hopkins University, Baltimore, MD)2 is evidence-based and uses a set of risk factors and community-level pandemic dynamics in the state of residence.3,4 It was compared to the list of CDC medical conditions that are considered to put an individual “at increased risk.” Both measures were calculated retrospectively on current participants to determine how many could safely attend in-person visits based on each risk assessment method. Results Sample characteristics of the 110 participants were: mean age: 49.5±13.7(24–76); mean BMI: 32.3±5.3(20.9–46.1); mean AHI: 24.3±21.4(5.1–110). Mortality Risk Calculator scores were: 91(82.7%) close to/lower than average [Level 1]; 12(10.9%) moderately elevated; 6(5.5%) substantially elevated; 1(0.9%) high; and 0(0%) very high [Level 5]. Using CDC guidance, 63 (57.3%) had at least one at-risk condition and 47 (42.7%) had 0. Using only Level 1 of the Risk Calculator would allow an additional 28 (25%) participants to attend in-person visits; using Levels 1 and 2 would allow an additional 40 (37%) participants. Conclusion Policies based on CDC at-risk conditions resulted in higher levels of participant exclusion in research during the COVID-19 pandemic than use of an evidence-based Mortality Risk Calculator. This analysis shows that researchers can use risk-adjusted scores to make informed decisions about study participation that balances both participant safety and research study progress. Support (if any) This project was supported in part by Department of Veteran Affairs VA HSRD IIR 16–277, VA RRD D2651-R, and VA San Diego Healthcare System Research Service.

Introduction Obstructive sleep apnea (OSA) is a condition that is prevalent, pernicious, and linked to the development and exacerbation of several disease processes. Positive airway pressure (PAP) is a highly efficacious intervention; however, initiation and adherence rates are poor. This represents a critical gap in care and a missed opportunity to reduce morbidity and mortality associated with OSA. The present study piloted a single session of cognitive behavioral therapy for treatment seeking (CBT-TS) among veterans diagnosed with obstructive sleep apnea and newly prescribed PAP. Methods Participants were asked to complete assessments at baseline and at two- and four-weeks post-intervention. A sample of 40 Veterans were enrolled in the study and completed a baseline interview, 27 completed CBT-TS. A matched comparison group of 64 veterans who did not receive the intervention was constructed using electronic medical record and PAP adherence data. Mann Whitney U and Chi Square tests were used to examine group differences in initiation and adherence. Results Participants who completed the CBT-TS session were more likely to initiate PAP (at least 3 consecutive nights of use) as compared to those receiving treatment as usual (TAU) [(CBT-TS; 96.3%; 26/27) versus (TAU; 64.1%; 41/64); X2(1, N = 91) = 10.16, p = .001]. Participants in the CBT-TS group also used their PAP devices for a greater number of nights over the first month than the comparison group [(CBT-TS; M = 21.7 (SD = 8.9), Mdn = 26.0) versus (TAU; M = 14.4 (SD = 12.6), Mdn = 15.5); U = 555.0, p = .007] and were more likely to use the device in an adherent manner (i.e., ≥4 hours use in an evening); [(CBT-TS; M = 15.1 (SD = 11.2); Mdn = 15.0) versus (TAU; M = 10.3 (SD = 11.2), Mdn = 6.5); U =630.0, p = .038]. Conclusion These preliminary data suggest that CBT-TS may have utility in increasing initiation of PAP and subsequent treatment adherence among Veterans diagnosed with OSA and newly prescribed PAP. Support (if any) This work was supported by the VA Center of Excellence for Suicide Prevention in the Finger Lakes Healthcare System.

The prevalence of diagnosed sleep disorders among Veterans treated at Veterans Affairs (VA) medical facilities increased significantly during fiscal years (FY) 2012 through 2018. Specifically, the prevalence of sleep-related breathing disorders (SRBD) increased from 5.5% in FY2012 to 22.2% in FY2018, and the prevalence of insomnia diagnoses increased from 7.4% in FY2012 to 11.8% in FY2018. Consequently, Veterans' demand for sleep medicine services also increased significantly between FY2012-2018, with steady increases in the annual number of VA sleep clinic appointments during this period (250,000 in FY 2012;720,000 in FY2018). Common co-morbid conditions among Veterans diagnosed with sleep disorders include obesity, diabetes, congestive heart failure, depression, post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI). To address this healthcare crisis, the Veterans Health Administration (VHA) developed and/or implemented numerous innovations to improve the quality and accessibility of sleep care services for Veterans. These innovations include a TeleSleep Enterprise-Wide Initiative to improve rural Veterans' access to sleep care; telehealth applications such as the Remote Veteran Apnea Management Platform (REVAMP), Clinical Video Telehealth, and CBT-i Coach; increased use of home sleep apnea testing (HSAT); and programs for Veterans who experience sleep disorders associated with obesity, PTSD, TBI and other conditions.

Excessive daytime sleepiness (EDS) is common in patients with obstructive sleep apnea (OSA) and continues to persist in many patients despite adequate OSA treatment. EDS in OSA is associated with decreased quality of life (QOL) as well as increased societal burden, which may impact health care utilization and costs. However, economic burden is often not the primary focus in the treatment of EDS in OSA. This targeted literature review aimed to examine the published literature on the economic burden of EDS in OSA. This review identified available literature using a targeted PubMed search strategy using search terms related to EDS in OSA in adults. Results demonstrate that there are few studies that detailed the direct costs associated with EDS in OSA, though several studies indicated an association between EDS in OSA and indirect economic burdens, including motor vehicle accidents (MVAs), near misses, work productivity, mood, and QOL. Data from the literature confirmed that persistent EDS in OSA following continuous positive airway pressure persists in 12%-65% of patients. Future studies should further describe the direct costs of EDS in OSA, quantify the cost associated with MVAs and lost work productivity, and detail QOL and social impacts of the condition.

PURPOSE OF REVIEW: Comorbidity of posttraumatic stress disorder (PTSD) and insomnia, nightmares, and obstructive sleep apnea (OSA) is high. We review recent research on psychotherapeutic and pharmacological interventions for sleep disorders in PTSD. RECENT FINDINGS: PTSD treatments decrease PTSD severity and nightmare frequency, but do not resolve OSA or insomnia. Research on whether insomnia hinders PTSD treatment shows mixed results; untreated OSA does interfere with PTSD treatment. Cognitive behavioral therapy for insomnia is the recommended treatment for insomnia; however, optimal ordering with PTSD treatment is unclear. PTSD treatment may be most useful for PTSD-related nightmares. CPAP therapy is recommended for OSA but adherence can be low. SUMMARY: Targeted treatment of sleep disorders in the context of PTSD offers a unique and underutilized opportunity to advance clinical care and research. Research is needed to create screening protocols, determine optimal order of treatment, and elucidate mechanisms between sleep and PTSD treatments.

Background: Participant recruitment can be a significant bottleneck in carrying out research studies. Connected health and mobile health platforms allow for the development of Web-based studies that can offer improvement in this domain. Sleep is of vital importance to the mental and physical health of all individuals, yet is understudied on a large scale or beyond the focus of sleep disorders. For this reason and owing to the availability of digital sleep tracking tools, sleep is well suited to being studied in a Web-based environment. Objective: The aim of this study was to investigate a method for speeding up the recruitment process and maximizing participant engagement using a novel approach, the Achievement Studies platform (Evidation Health, Inc, San Mateo, CA, USA), while carrying out a study that examined the relationship between participant sleep and daytime function. Methods: Participants could access the Web-based study platform at any time from any computer or Web-enabled device to complete study procedures and track study progress. Achievement community members were invited to the study and assessed for eligibility. Eligible participants completed an electronic informed consent process to enroll in the study and were subsequently invited to complete an electronic baseline questionnaire. Then, they were asked to connect a wearable device account through their study dashboard, which shared their device data with the research team. The data were used to provide objective sleep and activity metrics for the study. Participants who completed the baseline questionnaires were subsequently sent a daily single-item Sleepiness Checker activity for 7 consecutive days at baseline and every 3 months thereafter for 1 year. Results: Overall, 1156 participants enrolled in the study within a 5-day recruitment window. In the 1st hour, the enrollment rate was 6.6 participants per minute (394 per hour). In the first 24 hours, the enrollment rate was 0.8 participants per minute (47 participants per hour). Overall, 1132 participants completed the baseline questionnaires (1132/1156, 97.9%) and 1047 participants completed the initial Sleepiness Checker activity (1047/1156, 90.6%). Furthermore, 1000 participants provided activity-specific wearable data (1000/1156, 86.5%) and 982 provided sleep-specific wearable data (982/1156, 84.9%). Conclusions: The Achievement Studies platform allowed for rapid recruitment and high study engagement (survey completion and device data sharing). This approach to carrying out research appears promising. However, conducting research in this way requires that participants have internet access and own and use a wearable device. As such, our sample may not be representative of the general population.

STUDY OBJECTIVES: Few population-based studies have explored how excessive sleepiness (ES) contributes to burden of illness among patients with obstructive sleep apnea (OSA). METHODS: This study utilized data from the annual, cross-sectional 2016 US National Health and Wellness Survey. Respondents self-reporting an OSA diagnosis were categorized as having ES (Epworth Sleepiness Scale [ESS] score ≥ 11) or not having ES (ESS score < 11). Comorbidities, health-related quality of life (HRQoL), and productivity were examined in three groups: OSA with ES (n = 731), OSA without ES (n = 1,452), and non-OSA controls (n = 86,961). RESULTS: The OSA with ES group had significantly higher proportions of respondents reporting depression (62.4% versus 48.0%), gastroesophageal reflux disease (39.0% versus 29.4%), asthma (26.3% versus 20.7%), and angina (7.8% versus 6.7%) compared to the OSA without ES group (P < .05). After controlling for covariates, the OSA with ES group had significantly lower (worse) scores for mental component score (41.81 versus 45.65 versus 47.81), physical component score (46.62 versus 48.68 versus 51.36), and SF-6D (0.65 versus 0.69 versus 0.73) compared with OSA without ES and non-OSA controls (all P < .001). The OSA with ES group had significantly higher (greater burden) mean rates of presenteeism (25.98% impairment versus 19.24% versus 14.75%), work impairment (29.41% versus 21.82% versus 16.85%), and activity impairment (31.09% versus 25.46% versus 19.93%) compared with OSA without ES and non-OSA controls (all P < .01) after controlling for covariates. CONCLUSIONS: OSA with ES is associated with higher prevalence of comorbidities, reduced HRQoL, and greater impairment in productivity compared to OSA without ES and compared to non-OSA controls. CITATION: Stepnowsky C, Sarmiento KF, Bujanover S, Villa KF, Li VW, Flores NM. Comorbidities, health-related quality of life, and work productivity among people with obstructive sleep apnea with excessive sleepiness: findings from the 2016 US National Health and Wellness Survey. J Clin Sleep Med. 2019;15(2):235–243.

The Veterans Health Administration (VHA) represents one of the largest integrated health-care systems in the country. In 2012, the Veterans Affairs Sleep Network (VASN) sought to identify available sleep resources at VA medical centers (VAMCs) across the country through a national sleep inventory. The sleep inventory was administered at the annual 2012 VA Sleep Practitioners meeting and by email to sleep contacts at each VAMC. National prosthetics contacts were used to identify personnel at VAMCs without established sleep programs. Follow-up emails and telephone calls were made through March 2013. One hundred eleven VA medical centers were included for analysis. Thirty-nine programs did not respond, and 10 were considered “satellites,” referring all sleep services to a larger neighboring VAMC. Sleep programs were stratified based on extent of services offered (i.e., in-lab and home testing, sleep specialty clinics, cognitive behavioral therapy for insomnia (CBT-i)): 28 % were complex sleep programs (CSPs), 46 % were intermediate (ISPs), 9 % were standard (SSPs), and 17 % offered no formal sleep services. Overall, 138,175 clinic visits and 90,904 sleep testing encounters were provided in fiscal year 2011 by 112.1 physicians and clinical psychologists, 100.4 sleep technologists, and 115.3 respiratory therapists. More than half of all programs had home testing and CBT-i programs, and 26 % utilized sleep telehealth. The 2012 VA sleep inventory suggests considerable variability in sleep services within the VA. Demand for sleep services is high, with programs using home testing, sleep telehealth, and a growing number of mid-level providers to improve access to care.

Obstructive sleep apnea (OSA) is a widespread condition that adversely affects physical health and cognitive functioning. The prevailing treatment for OSA is continuous positive airway pressure (CPAP), but therapeutic benefits are dependent on consistent use. Our goal was to investigate the relationship between CPAP adherence and measures of sustained attention in patients with OSA. Our hypothesis was that the Psychomotor Vigilance Task (PVT) would be sensitive to attention-related improvements resulting from CPAP use.This study was a secondary analysis of a larger clinical trial. Treatment adherence was determined from CPAP use data. Validated sleep-related questionnaires and a sustained-attention and alertness test (PVT) were administered to participants at baseline and at the 6-month time point.Over a 6-month time period, the average CPAP adherence was 3.32 h/night (standard deviation [SD] = 2.53), average improvement in PVT minor lapses was -4.77 (SD = 13.2), and average improvement in PVT reaction time was -73.1 milliseconds (standard deviation = 211). Multiple linear regression analysis showed that higher CPAP adherence was significantly associated with a greater reduction in minor lapses in attention after 6 months of continuous treatment with CPAP therapy (β = -0.72, standard error = 0.34,The results of this study showed that higher levels of CPAP adherence were associated with significant improvements in vigilance. Because the PVT is a performance-based measure that is not influenced by prior learning and is not subjective, it may be an important supplement to patient self-reported assessments.Name: Effect of Self-Management on Improving Sleep Apnea Outcomes, URL: https://clinicaltrials.gov/ct2/show/NCT00310310, Identifier: NCT00310310.

Mobile health (mHealth) refers to the use of mobile technology (e.g., smartphones) and software (i.e., applications) to facilitate or enhance health care. Several mHealth programs act as either stand-alone aids for Veterans with post-traumatic stress disorder (PTSD) or adjuncts to conventional psychotherapy approaches. Veterans enrolled in a Veterans Affairs outpatient treatment program for PTSD (N = 188) completed anonymous questionnaires that assessed Veterans' access to mHealth-capable devices and their utilization of and interest in mHealth programs for PTSD. The majority of respondents (n = 142, 76%) reported having access to a cell phone or tablet capable of running applications, but only a small group (n = 18) reported use of existing mHealth programs for PTSD. Age significantly predicted ownership of mHealth devices, but not utilization or interest in mHealth applications among device owners. Around 56% to 76% of respondents with access indicated that they were interested in trying mHealth programs for such issues as anger management, sleep hygiene, and management of anxiety symptoms. Findings from this sample suggest that Veterans have adequate access to, and interest in, using mHealth applications to warrant continued development and evaluation of mobile applications for the treatment of PTSD and other mental health conditions.

Introduction: Positive airway pressure (PAP) therapy is the gold-standard for obstructive sleep apnea (OSA) management. While it is known that PAP is efficacious for controlling breathing events during sleep when it is worn at the right pressure for the amount of time prescribed, there is less clear data on how well it improves sleep quality. There are few studies that have examined the effectiveness of PAP therapy on sleep quality. Methods: OSA participants (n = 241) from a larger trial examining a PAP adherence were included. Participants were provided with PAP instruction and followed at 2 months and 4 months. PAP adherence was measured as the number of hours per night at prescribed pressure, an objective measure of treatment adherence. The Pittsburgh Sleep Quality Index (PSQI) was used as the primary measure of sleep quality. Results: The PSQI was significantly correlated with PAP adherence at both the 2-month and 4-month time points, such that lower sleep quality was associated with lower PAP use. This finding held for the sleep disturbance subscale of the PSQI. Over 55% of those using PAP therapy at the 4-month time point continued to report significantly disturbed sleep. Discussion: This study shows that PAP therapy does not appear to improve sleep quality to a degree that would be expected. Over half of those patients using PAP therapy still experienced disturbed sleep. Whether the disturbed sleep is directly attributable to the PAP device itself or to disturbed sleep secondary to uncontrolled OSA when PAP is not worn is worthy of further investigation.

ObjectivesElectroencephalography (EEG) assessment in research and clinical studies is limited by the patient burden of multiple electrodes and the time needed to manually score records. The objective of our study was to investigate the accuracy of an automated sleep-staging algorithm which is based on a single bipolar EEG signal.MethodsThree raters each manually scored the polysomnographic (PSG) records from 44 patients referred for sleep evaluation. Twenty-one PSG records were scored by Rechtschaffen and Kales (R&K) criteria (group 1) and 23 PSGs were scored by American Academy of Sleep Medicine (AASM) 2007 criteria (group 2). Majority agreement was present in 98.4% of epochs and was used for comparison to automated scoring from a single EEG lead derived from the left and right electrooculogram.ResultsThe κ coefficients for interrater manual scoring ranged from 0.46 to 0.89. The κ coefficient for the auto algorithm vs manual scoring by rater ranged from 0.42 to 0.63 and was 0.61 (group 1, κ=0.61 and group 2, κ=0.62) for majority agreement for all studies. The mean positive percent agreement across subjects and stages was 72.6%, approximately 80% for stages wake (78.3%), stage 2 sleep (N2) (80.9%), and stage 3 sleep (N3) (78.1%); the percentage slightly decreased to 73.2% for rapid eye movement (REM) sleep and dropped to 31.9% for stage 1 sleep (N1). Differences in agreement were observed based on raters, obstructive sleep apnea (OSA) severity, medications, and signal quality.ConclusionsOur study demonstrated that automated scoring of sleep obtained from a single-channel of forehead EEG results in agreement to majority manual scoring are similar to results obtained from studies of manual interrater agreement. The benefit in assessing auto-staging accuracy with consensus agreement across multiple raters is most apparent in patients with OSA; additionally, assessing auto-staging accuracy limited disagreements in patients on medications and in those with compromised signal quality.

Older adults with chronic kidney disease have a high rate of uncontrolled hypertension. Home monitoring of blood pressure (BP) is an integral part of management, but requires that patients bring records to clinic visits. Telemonitoring interventions, however, have not targeted older, less technologically-skilled populations.Veterans with stage 3 or greater chronic kidney disease and uncontrolled hypertension were randomized to a novel telemonitoring device pairing a Bluetooth-enabled BP cuff with an Internet-enabled hub, which wirelessly transmitted readings (n=28), or usual care (n=15). Home recordings were reviewed weekly and telemonitoring participants were contacted if BP was above goal. The prespecified primary endpoints were improved data exchange and device acceptability. Secondary endpoint was BP change.Forty-three participants (average age 68 years, 75% white) completed the 6-month study. Average start-of-study BP was 147/78 mmHg. Those in the intervention arm had a median of 29 (IQR 22, 53) transmitted BP readings per month, with 78% continuing to use the device regularly, whereas only 20% of those in the usual care group brought readings to in-person visits. The median number of telephone contacts triggered by the wireless monitoring was 2 (IQR 1, 4) per patient. Both groups had a significant improvement in systolic BP (P0.05, for both changes); systolic BP fell a median of 13 mmHg in monitored participants compared with 8.5 mmHg in usual care participants (P for comparison 0.31).This low-cost wireless monitoring strategy led to greater sharing of data between patients and clinic and produced a trend toward improvements in BP control over usual care at 6 months.

BACKGROUND/OBJECTIVE: Few studies have examined whether chronic heart failure (HF) outcomes can be improved by increasing patient engagement (known as activation) in care and capabilities for self-care management. The objective was to determine the efficacy of a patient activation intervention compared with usual care on activation, self-care management, hospitalizations, and emergency department visits in patients with HF. METHODS: This study used a randomized, 2-group, repeated-measures design. After consent was given, 84 participants were stratified by activation level and randomly assigned to usual care (n = 41) or usual care plus the intervention (n = 43). The primary outcomes and measures were patient activation using the Patient Activation Measure (PAM), self-management using the Self-Care of Heart Failure Index (SCHFI) and the Medical Outcomes Study (MOS) Specific Adherence Scale, and hospitalizations and emergency department visits. The intervention was a 6-month program to increase activation and improve HF self-management behaviors, such as adhering to medications and implementing health behavior goals. RESULTS: Participants were primarily male (99%), were white (77%), and had New York Heart Association III stage (52%). The mean (SD) age was 66 (11) years, and 71% reported 3 or more comorbidities. The intervention group compared with the usual care group showed a significant increase in activation/PAM scores from baseline to 6 months. No significant group-by-time interactions were found for the SCHFI scales. Although the baseline MOS Specific Adherence Scale mean was lower in the intervention group, results showed a significant group-by-time effect with the intervention group improving more over time. Participants in the intervention group had fewer hospitalizations compared with the usual care group when the baseline activation/PAM level was low or high. CONCLUSION: This study supports the importance of targeted interventions to improve patient activation or engagement in HF care. Further work is needed related to HF self-management measurement and outcomes.

Study objectivesPosttraumatic stress disorder (PTSD) is common among veterans of the military, with sleep disturbance as a hallmark manifestation. A growing body of research has suggested a link between obstructive sleep apnea and PTSD, potentially due to obstructive sleep apnea (OSA) related sleep disruption, or via other mechanisms. We examined the hypothesis that treatment of OSA with positive airway pressure would reduce PTSD symptoms over 6 months.MethodsA prospective study of Veterans with confirmed PTSD and new diagnosis of OSA not yet using PAP therapy were recruited from a Veteran's Affairs sleep medicine clinic. All subjects were instructed to use PAP each night. Assessments were performed at 3 and 6 months. The primary outcome was a reduction in PTSD symptoms at 6 months.ResultsFifty-nine subjects were enrolled; 32 remained in the study at 6 months. A significant reduction in PTSD symptoms, measured by PCL-S score was observed over the course of the study (60.6 ± 2.7 versus 52.3 ± 3.2 points; p < 0.001). Improvement was also seen in measures of sleepiness, sleep quality, and daytime functioning, as well as depression and quality of life. Percentage of nights in which PAP was used, but not mean hours used per night, was predictive of improvement.ConclusionsTreatment of OSA with PAP therapy is associated with improvement in PTSD symptoms, although the mechanism is unclear. Nonetheless, PAP should be considered an important component of PTSD treatment for those with concurrent OSA. Improving PAP compliance is a challenge in this patient population warranting further investigation.Clinical trial registrationClinicalTrials.gov, ID: NCT02019914.CommentaryA commentary on this article appears in this issue on page 5.

Study Objectives. Continuous positive airway pressure (CPAP) therapy is efficacious for treating obstructive sleep apnea (OSA), but recent studies with placebo CPAP (CPAP administered at subtherapeutic pressure) have revealed nonspecific (or placebo) responses to CPAP treatment. This study examined baseline psychological factors associated with beneficial effects from placebo CPAP treatment.Participants. Twenty-five participants were studied with polysomnography at baseline and after treatment with placebo CPAP.Design. Participants were randomized to either CPAP treatment or placebo CPAP. Baseline mood was assessed with the Profile of Mood States (POMS). Total mood disturbance (POMS-Total) was obtained by summing the six POMS subscale scores, with Vigor weighted negatively. The dependent variable was changed in apnea-hypopnea index (ΔAHI), calculated by subtracting pre- from post-CPAP AHI. Negative values implied improvement. Hierarchical regression analysis was performed, with pre-CPAP AHI added as a covariate to control for baseline OSA severity.Results. Baseline emotional distress predicted the drop in AHI in response to placebo CPAP. Highly distressed patients showed greater placebo response, with a 34% drop (i.e., improvement) in AHI.Conclusion. These findings underscore the importance of placebo-controlled studies of CPAP treatment. Whereas such trials are routinely included in drug trials, this paper argues for their importance even in mechanical-oriented sleep interventions.

OBJECTIVES OR BACKGROUND: Obstructive Sleep Apnea (OSA) is characterized by partial or complete cessation of breath during sleep. OSA is associated with increased cardiovascular risk as well as psychosocial complications such as daytime somnolence, depression, and fatigue. The goal of the present study was to better understand fatigue in OSA by examining self-reported sleep quality, depressive symptoms, excessive daytime sleepiness, and OSA severity in a group of newly diagnosed OSA patients.Two hundred and forty newly diagnosed OSA patients enrolled in the study. Participants completed several questionnaires at baseline.Depressive symptoms accounted for 15% of variance in fatigue beyond that of demographics and OSA severity (p0.001). Self-reported sleep quality accounted for 11% of variance beyond that of depressive symptoms (p0.001). The total model accounted for 48% of the variance in fatigue. Post hoc analysis found that the total model accounted for only 14% of the variance in sleepiness (as measured by the Epworth Sleepiness Scale).The current study confirms the findings of previous OSA studies, which found depressive symptoms have a greater association with fatigue than OSA disease severity variables. This study extends those findings by showing that self-reported sleep quality is independently associated with fatigue, even after taking into account demographic, comorbid conditions, OSA disease severity, sleepiness, and depressive symptoms. The role of sleep quality as an independent contributor to daytime fatigue in OSA may be under appreciated. Sleep quality should be closely followed in the clinical management of OSA.

Summary. Chronic hepatitis C (HCV) infection afflicts millions of people worldwide. While antiviral treatments are effective for some patients, many either cannot or choose not to receive antiviral treatment. Education about behavioural changes like alcohol avoidance and symptom management, in contrast, is universally recommended, particularly in HCV-infected persons from disadvantaged groups where liver risk factors are most prevalent. Self-management interventions are one option for fostering improved HCV knowledge and health-related quality of life (HRQOL). One hundred and thirty-two patients with VA with HCV (mean age of 54.6, 95% men, 41% ethnic minority, 83% unmarried, 72% unemployed/disabled, 48% homeless in last 5 years) were randomized to either a 6-week self-management workshop or an information-only intervention. The weekly 2-h self-management sessions were based on cognitive-behavioural principles and were adapted from an existing self-management programme that has been efficacious with other chronic diseases. HCV-specific modules were added. Outcomes including HRQOL, HCV knowledge, self-efficacy, depression, energy and health distress were measured at baseline and 6 weeks later. Data were analysed using ANOVA. When compared to the information-only group, participants attending the self-management workshop improved more on HCV knowledge (P