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Obesity is a dramatically increasing disease, accompanied with comorbidities such as cardiovascular disease and obstructive sleep apnea syndrome (OSAS). Both obesity and OSAS per se are associated with systemic inflammation. However, the multifactorial impact of obesity, OSAS, and its concomitant diseases on the immunological characteristics of circulating monocytes has not yet been fully resolved. Monocyte subsets of 82 patients with obesity were analyzed in whole blood measurements in terms of the CD14/CD16 cell surface expression patterns and different monocytic adhesion molecules using flow cytometry. Plasma levels of adipokines adiponectin and leptin of all patients were evaluated and correlated with accompanying cellular and clinical values. Whole blood measurements revealed a significant overall redistribution of CD14/CD16 monocyte subsets in patients with obesity. Monocytic adhesion molecules CD11a, CD11b, and CX3CR1 were significantly elevated. The observed alterations significantly correlated with plasma leptin levels and diabetes status as crucial amplifying factors. The additive impact of obesity, diabetes, and OSAS on the immunological balance of peripheral blood monocytes requires a coordinated regimen in terms of therapeutic treatment, respiratory support, and weight loss to improve the systemic immunity in these patients.

Computational fluid dynamics can be used to analyze the flow pattern and the anatomical predisposition of the airway collapse in patient-specific simulations of sleep apnea patients. Especially the nasal geometry is a major challenge, because of the complex structures and high calculation effort. Due to this limitations the nasal cavity is often excluded. To investigate the influence of the exclusion of the nasal geometry on the flow in the pharynx, four digital models were created. One, which includes the complete nasal structure, and three simplified models, neglecting the nasal geometry using different cutting planes. Airflow simulations using the k-ε turbulence model are performed with an inlet flow rate of 10 l/min. The results show a good agreement of the average velocities. Deviations of the velocity and pressure values occur particularly in the region of the oropharynx and indicate that the type of simplification has a significant influence on the pressure distribution.

ZusammenfassungFür die Therapie verschiedener schlafbezogene Erkrankungen und das Schnarchen stehen mittlerweile mehrere Neurostimulationsverfahren zur Verfügung. Zur Behandlung der obstruktiven Schlafapnoe (OSA) existieren überwiegend Daten für die atmungsgesteuerte Hypoglossusnervstimulation (HNS), welche die Senkung der Tagesschläfrigkeit in der Epworth Sleepiness Scale (ESS) in zahlreichen Publikationen übereinstimmend und für mehrere Jahre stabil um gut 5 Punkte zeigen konnte. Die schlafbezogene Lebensqualität im Functional Outcomes of Sleep Questionnaire erbringt in mehreren Kohorten eine Besserung um gut 2 Punkte. Zahlreiche Arbeiten zeigen eine durchschnittliche Nutzung von 5 bis 6 Stunden. Unter Berücksichtigung kürzerer Nachsorgeintervalle und kleinerer Kohorten sinkt der ESS bei der unilateralen kontinuierlichen HNS um 4 und bei der bilateralen um 3 Punkte. Zur Behandlung der zentralen Schlafapnoe ist die transvenöse Stimulation der Nervus phrenicus zugelassen, bei welcher sich in einer Schlüsselstudie mit fünfjähriger Nachbeobachtung der ESS um 3 Punkte gesenkt werden konnte. Die Therapiezeit beträgt in einer Arbeit gut 5 Stunden. Mit der enoralen Stimulationstherapie gegen das Schnarchen konnte der ESS um gut 2 Punkte gesenkt und die schlafbezogene Lebensqualität sowohl des Schnarchenden als auch des Bettpartners gesteigert werden. Die Adhärenz zum täglichen Training für die nächtlichen Effekte wird mit 83% angegeben. Sowohl für die HNS, Phrenicusstimulation als auch die enorale Stimulationstherapie laufen weitere (Register-)Studien bzw. sind angekündigt, welche Patienten relevante Endpunkte berücksichtigen.

ZusammenfassungSialorrhoe, ein unkontrollierter, übermäßiger Speichelfluss aus dem Mund und in den Schlund, tritt als Begleitsymptom bei verschiedenen, v. a. neurologischen Erkrankungen im Kindes- und Erwachsenenalter auf. Mit IncobotulinumtoxinA (Xeomin, IncoBoNT/A, Merz Pharmaceuticals GmbH) steht seit 2019 ein zugelassenes Medikament für die Behandlung der Sialorrhoe zur Verfügung. Indikationsstellung, mögliche Therapieziele, Praxis der Behandlung und Management in besonderen Behandlungssituationen bilden den Schwerpunkt dieser konsentierten Praxis-Empfehlungen, die in interdisziplinärer Zusammenarbeit erfahrener Anwender entwickelt wurden. Ziel ist, den Zugang zur Therapie zu erleichtern und einen Beitrag zu einer qualifizierten Botulinumtoxin-Therapie zu leisten.

ZusammenfassungDie größten Speicheldrüsen sind die paarigen Gl. parotis und Gl. submandibularis. Der erwachsene Mensch produziert 1–1,5 l Speichel am Tag, die er regelmäßig abschluckt. Die häufigste Ursache eines vermehrten Speichelflusses mit einer Ansammlung von Speichel im Mund und Ausfluss (Sialorrhoe) ist eine Störung der Schluckfunktion. Seltener kann auch eine vermehrte Speichelsekretion, z. B. medikamentös bedingt, die Ursache sein. Eine Sialorrhoe beeinträchtigt die Lebensqualität erheblich und ist oft auch sozial stigmatisierend. Die Therapie umfasst konservative Maßnahmen wie die funktionelle Dysphagietherapie, orale oder transdermale Applikation von Anticholinergika sowie, in ausgewählten Fällen, invasive Therapien wie Bestrahlungen und Operationen. Seit 20 Jahren wird auch die lokale Injektion von Botulinumtoxin in die Speicheldrüsen erfolgreich therapeutisch eingesetzt. Durch die Zulassung von IncobotulinumtoxinA für die Behandlung von Kindern und Erwachsenen darf diese Maßnahme als Therapie der Wahl bei chronischer Sialorrhoe angesehen werden. Die Ergebnisse der Zulassungsstudien zeigen bei Kindern wie auch Erwachsenen eine hohe Effektivität und gute Verträglichkeit der Injektionsbehandlung.

Purpose Hypoglossal nerve stimulation (HNS) has been shown to treat obstructive sleep apnea (OSA) effectively. The aim of this study was to compare HNS with positive airway pressure (PAP) treatment regarding outcome parameters: (1) sleepiness, (2) apnea–hypopnea index (AHI), and (3) effectiveness. Methods Propensity score matching with nearest neighbor algorithm was used to compare outcomes of HNS and PAP therapy in a real-world setting. Data were collected at baseline and 12 months after initiating OSA treatment including demographics, Epworth Sleepiness Scale (ESS), AHI, and objective adherence data. To account for overall treatment efficacy, the mean disease alleviation (MDA) was calculated. Results Of 227 patients who received treatment consecutively, 126 could be matched 1:1 with regard to age, body mass index, and AHI. After matching, no statistically significant differences between the groups were found. A clinically important symptom improvement was seen at 12 months in both cohorts, though there was a greater difference in ESS improvement in patients treated with HNS (8.0 ± 5.1 points vs. 3.9 ± 6.8 points; p = 0.042). In both groups, mean posttreatment AHI was significantly reduced (HNS: 8.1 ± 6.3/h; PAP: 6.6 ± 8.0/h; p Conclusion Patients treated with HNS therapy had significantly greater improvements in daytime sleepiness compared to PAP therapy, while the mean reduction of AHI and overall effectiveness were comparable for both treatments. Trial registration ClinicalTrial.gov Identifier: NCT03756805.

Hypoglossal nerve stimulation (HGNS) has evolved as a novel and effective therapy for patients with moderate-to-severe obstructive sleep apnea. Despite positive published outcomes of HGNS, there exist uncertainties regarding proper patient selection, surgical technique, and the reporting of outcomes and individual factors that impact therapy effectiveness. According to current guidelines, this therapy is indicated for select patients, and recommendations are based on the Stimulation Therapy for Apnea Reduction or STAR trial. Ongoing research and physician experiences continuously improve methods to optimize the therapy. An understanding of the way in which airway anatomy, obstructive sleep apnea phenotypes, individual health status, psychological conditions, and comorbid sleep disorders influence the effectiveness of HGNS is essential to improve outcomes and expand therapy indications. This article presents discussions on current evidence, future directions, and research gaps for HGNS therapy from the 10th International Surgical Sleep Society expert research panel. CITATION: Suurna MV, Jacobowitz O, Chang J, et al. Improving outcomes of hypoglossal nerve stimulation therapy: current practice, future directions and research gaps. Proceedings of the 2019 International Sleep Surgery Society Research Forum. J Clin Sleep Med. 2021;17(12):2477–2487.

Introduction Upper airway stimulation (UAS) has become a viable treatment alternative for well selected patients with moderate to severe obstructive sleep apnea (OSA) who struggle to tolerate positive pressure (PAP) therapy. Post-market surveillance is required of medical device manufacturers to assess treatment outcomes, complications, and device failure. We aim to utilize this surveillance data to assess rates of revision and removal of the Inspire (Minneapolis, MN) UAS system in a real-world setting. Methods Post market surveillance data was compiled from manufacturer’s complaint handling system for explants and revisions of the hypoglossal nerve stimulator. Data collection began in January 2018 and was available through September 30 2022 at the time of analysis. Implant procedures from January 2018 through September 2021 were analyzed for events within one year of implant. Events were classified into categories. A subset of these devices implanted before September 30 2019 were analyzed for events between one and three years after implant. Results Between Jan 01 2018 and Sep 30 2021, 15282 devices were implanted. Within one year of the implant, 121 devices (0.8%) were explanted for: infection (66), elective (32), MRI (10), other (10), and twiddler syndrome (3). Surgical revisions were required for 245 patients (1.6%) for: surgical correction (139), device defect (81), other (21), cardioversion (2), twiddler syndrome (1), and MRI (1). A subset of 5080 of these devices were implanted prior to September 30 2019. Between one year and three years following implant 119 devices (2.3%) were explanted for: elective (58), MRI (35), infection (15), Other (9), and twiddler syndrome (2). Surgical revisions were performed for 160 patients (3.1%) for: surgical correction (64), device defect (57), other (32), twiddler syndrome (5), and cardioversion (2). Conclusion As with any implantable medical device, a certain rate of revision and explant is expected for device, patient, and medical indications. The rate of UAS revision and explantation is low at both the 1 year and 3 year time points. UAS implantation is a safe alternative to CPAP for well selected patients with a low rate of unexpected reoperation for either revision or hardware explantation. Support (if any) Inspire Medical

Since the first statement of the German Society of Oto-Rhino-Laryngology, hypoglossal nerve stimulation (HNS) is meanwhile an established treatment option for obstructive sleep apnea (OSA). There are three HNS systems available in Germany which differ in their technical details of the underlying comparable basic principle. For the unilateral HNS with respiratory sensing, several comparative studies, high-volume register analysis and long-term reports exist. The continuous HNS without respiratory sensing does not require a sleep endoscopy for indication. For the bilateral continuous HNS as the single partially implantable device, a feasibility study exists. For indication, the assessment of positive airway pressure failure by sleep medicine is crucial, and the decision for HNS should be made in discussion of other treatment options for at least moderate OSA. The implantation center holds primarily responsibility among the interdisciplinary sleep team and is primary contact for the patient in problems. This depicts why structural processes are required to secure outcome quality and minimize the complications. The aftercare of HNS patients can be provided interdisciplinary and by different medical institutions, whereat, minimal reporting standards to document outcome and usage are recommended.

A functional hypersalivation reduces patient's quality of life by the need of repeated changes of cloths, skin damage around the mouth and reduced personal contacts. The indication to treat hypersalivation is justified furthermore when respiratory infections by saliva aspiration occur. Transnasal swallowing endoscopy allows to evaluate sufficiently dysphagia with limited risks. With this method therapy options can be judged for effectiveness. There are other additional radiologic assessments to complete diagnostic. Swallowing therapy should be initiated as first-line approach for hypersalivation and offers several treatment concepts to overcome the syndrome. Glycopyrrolate bromid received approval for children and adolescents as it reduces saliva flow relevantly with limited risk. Other anticholinergic drugs are restricted in use because of their side effects and off-label-use situation. Ultrasound guided injections of botulinum toxine in salivary glands are an established treatment option since decades. Meanwhile, the evidence for this method has improved, so Incobotulinum toxine is an approved therapy for chronic hypersalivation in adults, whereby new injections are needed about every four months. In the light of effective medical options, surgical approaches such as salivary duct relocation are recommended less often today because of invasiveness and failure. Radiotherapy is reserved mainly for neurodegenerative diseases and shows good response, but the cancer induction risks need to be discussed. A close follow-up regime is necessary to establish compliance not only by the patient, but also by his family and caregivers. By this, treatment effects can be optimized and therapies can be adjusted individually.

Obstructive sleep apnea syndrome (OSAS) represents a substantial disease of recurrent sleep fragmentation, leading to intermittent hypoxia and subsequent diseases such as cardiovascular, metabolic, or cognitive dysfunctions. In addition, OSAS is considered as low-grade systemic inflammation, which is associated with a higher incidence of cancer, severity of infections, and an overall immune dysregulation. This research project aims to comprehensively investigate the interplay of wholesome sleep and the immune functions of circulating monocytes and T cells in OSAS patients, which are known to be affected by oxidative stress. We studied the distribution of the CD14/CD16 characterized monocyte subsets in peripheral blood as well as their PD-L1 expression and complex formation with T cells. Furthermore, a detailed analysis of T cell subsets with regard to their PD-1 and PD-L1 expression was performed. Data revealed a decrease of classical monocytes accompanied by an increase of both CD16+ monocyte subsets in OSAS patients that was positively correlated with the body mass index. OSAS patients revealed an increased PD-1 and PD-L1 expression in T cells and monocytes, respectively, which was linked to the severity of monocyte subset alterations. The complex formation of monocytes and T cells was also elevated in OSAS patients, which indicates a deregulated PD-1/PD-L1 cross-talk between these cells. Our data show for the first time, to our knowledge, massive alterations of peripheral monocyte subsets in response to OSAS and its accompanying phenomena.

ZusammenfassungDie Stimulation des Nervus hypoglossus (HNS) zur Behandlung der obstruktiven Schlafapnoe (OSA) hat seit der ersten Stellungnahme der Arbeitsgemeinschaft Schlafmedizin der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie (DGHNO) einen festen Stellenwert erhalten. Die vorhandenen 3 Systeme unterscheiden sich in der technischen Ausgestaltung des ähnlichen Grundprinzips. Für die unilaterale atmungsgesteuerte HNS existieren hier mehrere Vergleichsstudien, Registeranalysen mit 4-stelligen Patientenzahlen und mehrjährigen Nachsorgeergebnissen. Die kontinuierliche HNS verzichtet auf die Atmungserkennung, und im Gegensatz zum atmungsgesteuerten HNS ist eine Schlafendoskopie zur Indikationsstellung nicht notwendig. Die bilaterale kontinuierliche HNS ist als einziges Verfahren teilimplantierbar; hierzu liegen erste Machbarkeitsstudien vor. Wesentlich für die Indikation ist die mit schlafmedizinischer Expertise beurteilte Non-Adhärenz der Überdrucktherapie bei einer mindestens mittelgradigen OSA in individueller Abwägung von weiteren Therapieoptionen. Die implantierende Klinik steht im Mittelpunkt der interdisziplinären Therapieverantwortung und ist bei Therapieproblemen Hauptansprechpartner. Dies erklärt die strukturellen Anforderungen zur Sicherung der Ergebnisqualität und Minimierung von Komplikationen. Die Nachsorge der HNS-versorgten Patienten kann sehr gut sektoren- und fachdisziplinübergreifend erfolgen, wobei Mindestangaben zur Behandlungswirkung und Nutzung dokumentiert werden sollten.

Rationale: Understand the impact of insurance coverage on sleep apnea outcomes for patients awaiting upper airway stimulation.Objectives: Examine the natural history of impact of upper airway stimu...

Several neurostimulation devices exist for the treatment of various sleep-related breathing diseases. The most data for hypoglossal nerve stimulation (HNS) in the therapy of obstructive sleep apnea (OSA) derive the HNS with respiratory sensing. Herewith, daytime sleepiness measured with the Epworth Sleepiness Scale (ESS) was improved in several publications by 5 points with a stability shown for up to several years. Sleep related quality of life, documented with the Functional Outcomes of Sleep Questionnaire, increased by 2 points. In many cohorts showed a mean usage of 5 to 6 hours per night. Under the consideration of shorter follow-ups and smaller group sizes, the ESS improved by 4 under unilateral continuous HNS and by 3 under bilateral HNS. Transvenous stimulation of the phrenic nerve is approved for the treatment in central sleep apnea. In a pivotal trial with 5 year follow-up data, an ESS reduction is documented by 3 points. There is one publication describing a usage of more than 5 hours. The daytime enoral neuromuscular electrical therapy improved ESS (2 points) and sleep-related quality of life of the snoring patients and the bed partner. The daytime training for the effects during the night adherence is given with 83%. For all described devices, there are running or announced studies and/or registry trials that consider patient related outcome.Für die Therapie verschiedener schlafbezogene Erkrankungen und das Schnarchen stehen mittlerweile mehrere Neurostimulationsverfahren zur Verfügung. Zur Behandlung der obstruktiven Schlafapnoe (OSA) existieren überwiegend Daten für die atmungsgesteuerte Hypoglossusnervstimulation (HNS), welche die Senkung der Tagesschläfrigkeit in der Epworth Sleepiness Scale (ESS) in zahlreichen Publikationen übereinstimmend und für mehrere Jahre stabil um gut 5 Punkte zeigen konnte. Die schlafbezogene Lebensqualität im Functional Outcomes of Sleep Questionnaire erbringt in mehreren Kohorten eine Besserung um gut 2 Punkte. Zahlreiche Arbeiten zeigen eine durchschnittliche Nutzung von 5 bis 6 Stunden. Unter Berücksichtigung kürzerer Nachsorgeintervalle und kleinerer Kohorten sinkt der ESS bei der unilateralen kontinuierlichen HNS um 4 und bei der bilateralen um 3 Punkte. Zur Behandlung der zentralen Schlafapnoe ist die transvenöse Stimulation der Nervus phrenicus zugelassen, bei welcher sich in einer Schlüsselstudie mit fünfjähriger Nachbeobachtung der ESS um 3 Punkte gesenkt werden konnte. Die Therapiezeit beträgt in einer Arbeit gut 5 Stunden. Mit der enoralen Stimulationstherapie gegen das Schnarchen konnte der ESS um gut 2 Punkte gesenkt und die schlafbezogene Lebensqualität sowohl des Schnarchenden als auch des Bettpartners gesteigert werden. Die Adhärenz zum täglichen Training für die nächtlichen Effekte wird mit 83% angegeben. Sowohl für die HNS, Phrenicusstimulation als auch die enorale Stimulationstherapie laufen weitere (Register-)Studien bzw. sind angekündigt, welche Patienten relevante Endpunkte berücksichtigen.

Sialorrhea, uncontrolled, excessive drooling, accompanies different, mostly neurological disorders from childhood to adulthood. With incobotulinumtoxinA (Xeomin, IncoBoNT/A, Merz Pharmaceuticals GmbH), an approved medication for the treatment of sialorrhea has been available since 2019. Patient selection, possible therapy goals, treatment and the management of specific treatment situations build the focus of this interdisciplinary expert consensus recommendations with the intent to facilitate access to treatment and to contribute to qualified botulinum toxin therapy.Sialorrhoe, ein unkontrollierter, übermäßiger Speichelfluss aus dem Mund und in den Schlund, tritt als Begleitsymptom bei verschiedenen, v. a. neurologischen Erkrankungen im Kindes- und Erwachsenenalter auf. Mit IncobotulinumtoxinA (Xeomin, IncoBoNT/A, Merz Pharmaceuticals GmbH) steht seit 2019 ein zugelassenes Medikament für die Behandlung der Sialorrhoe zur Verfügung. Indikationsstellung, mögliche Therapieziele, Praxis der Behandlung und Management in besonderen Behandlungssituationen bilden den Schwerpunkt dieser konsentierten Praxis-Empfehlungen, die in interdisziplinärer Zusammenarbeit erfahrener Anwender entwickelt wurden. Ziel ist, den Zugang zur Therapie zu erleichtern und einen Beitrag zu einer qualifizierten Botulinumtoxin-Therapie zu leisten.

The most important salivary glands are the paired parotid and submandibular glands. Adults produce 1 to 1.5 liters of saliva which are then regularly swallowed. When the act of swallowing is disturbed, salivation occurs. More rarely, the cause can be found in increased saliva production, for example, when caused through medication. Sialorrhea impairs the quality of life substantially and is frequently often socially stigmatizing. Therapy includes conservative measures such as functional dysphagia therapy, oral or transdermal application of anticholinergics, as well as, in selected cases, radiation and surgical measures. Over the last 20 years, local injection of botulinum toxin has been successfully applied in the treatment of this condition. With approval of incobotulinumtoxinA toxin for children and adults, this procedure will become the therapy of choice for chronic sialorrhea. The results of the phase III registration trials have demonstrated high efficacy and good safety of the injection treatment in both children and adults.Die größten Speicheldrüsen sind die paarigen Gl. parotis und Gl. submandibularis. Der erwachsene Mensch produziert 1–1,5 l Speichel am Tag, die er regelmäßig abschluckt. Die häufigste Ursache eines vermehrten Speichelflusses mit einer Ansammlung von Speichel im Mund und Ausfluss (Sialorrhoe) ist eine Störung der Schluckfunktion. Seltener kann auch eine vermehrte Speichelsekretion, z. B. medikamentös bedingt, die Ursache sein. Eine Sialorrhoe beeinträchtigt die Lebensqualität erheblich und ist oft auch sozial stigmatisierend. Die Therapie umfasst konservative Maßnahmen wie die funktionelle Dysphagietherapie, orale oder transdermale Applikation von Anticholinergika sowie, in ausgewählten Fällen, invasive Therapien wie Bestrahlungen und Operationen. Seit 20 Jahren wird auch die lokale Injektion von Botulinumtoxin in die Speicheldrüsen erfolgreich therapeutisch eingesetzt. Durch die Zulassung von IncobotulinumtoxinA für die Behandlung von Kindern und Erwachsenen darf diese Maßnahme als Therapie der Wahl bei chronischer Sialorrhoe angesehen werden. Die Ergebnisse der Zulassungsstudien zeigen bei Kindern wie auch Erwachsenen eine hohe Effektivität und gute Verträglichkeit der Injektionsbehandlung.

Background Upper Airway Stimulation (UAS) is a well-established therapy option for obstructive sleep apnea (OSA). Aims There are no data on whether respiratory sensing contributes to successful UAS therapy. Materials & methods After initial measurements of 3 implanted patients (M1), the sensing signal was inverted (M2) without changing other parameters. Two weeks later, the signal was converted back again, and the sensitivity of breathing cycle detection was turned to a very low state (M3). Results At M2 and M3, the apnea-hypopnea index and oxygen desaturation index increased. Discussion Correct respiratory sensing is important for controlling OSA using UAS. Conclusions Therefore, implant centers should should optimize respiratory sensing placement and adjustment.

Hypoglossal nerve stimulation is an established treatment option for obstructive sleep apnea in selected patients. A unilateral hypoglossal nerve stimulation system was approved a decade ago, yet the physiological effect of unilateral hypoglossal stimulation on bilateral tongue motion remains unclear. This study examined how electrode configuration, stimulation cuff position, or body mass index influenced the contralateral genioglossus electromyography (EMG) signal. Twenty-nine patients underwent three EMG recordings in a polysomnographic setting after being implanted with a unilateral hypoglossal nerve stimulator for at least 6 months. The ratio of EMG signals between the ipsi- and contralateral sides was evaluated. No difference in EMG signals was demonstrated based on electrode configurations, stimulation-cuff position, body-mass-index, or sleep apnea severity, even in patients with right tongue protrusion only. Our findings may be explained by a significant level of cross-innervation and by a smaller and less variable circumferential electric field than expected based on prior biophysical models. A patient's individual anatomy needs to be considered during therapy titration in order to achieve an optimal response.

BACKGROUND: Sialorrhea is a troublesome symptom in a variety of neurological diseases. Recently, local injection of botulinum toxin into the salivary glands was approved for treatment of sialorrhea, and injection guidance by anatomical landmarks was suggested. OBJECTIVE: To compare the accuracy of ultrasound versus previously proposed anatomical landmarks for localizing the salivary glands. METHODS: In a cross‐sectional study in 21 adults, landmark positions (LM) of the parotid gland (PG) and the submandibular gland (SG) were identified following published recommendations. The ultrasound position (US) was defined as the position representing the maximum gland thickness. The distance between positions, gland thickness, and optimal injection depth were recorded by US. RESULTS: Gland thickness differed significantly between LM and US positions (PG, 4 vs. 17.8 mm; P

Comorbid insomnia may impact outcomes of patients with obstructive sleep apnea (OSA) receiving hypoglossal nerve stimulation with respiratory sensing (HNS) therapy. To examine whether the presence of insomnia measured using the Insomnia Severity Index (ISI) is associated with patient-reported outcomes and objective OSA measures in patients receiving HNS therapy.In this retrospective chart review, patients with an HNS implant and ISI score at follow-up assessment were categorized as having moderate/severe insomnia or no/subthreshold insomnia. OSA-related data (Apnea Hypopnea Index, AHI; Oxygen Desaturation Index, ODI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and overall patient satisfaction was compared between these patient categories. Correlations between ISI scores and each of these variables were examined.Of the 132 patients, 26% had moderate/severe insomnia at follow-up assessment. ESS and FOSQ scores were worse in the insomnia group at baseline, follow-up, and in the change from baseline, but AHI and ODI scores did not differ between patients with and without insomnia. Frequency of overall satisfaction at follow-up was lower in the insomnia group (58.8% vs. 92.8% with no insomnia,Insomnia is associated with worse patient-reported outcomes of daytime sleepiness and sleep-related quality of life in patients with OSA receiving HNS therapy. Depression is more prevalent in patients with comorbid insomnia. The ISI may help physicians to address comorbid insomnia and achieve high patient satisfaction and adherence to HNS therapy.4.

Obstructive sleep apnea (OSA) is characterized by nocturnal breathing intermissions resulting in oxidative stress and eventually, a low-grade systemic inflammation. The study aimed to investigate the impact of positive airway pressure (PAP) therapy on the inflammatory milieu as measured by monocyte and T cell phenotypic alterations. Participants were assessed for their OSA severity before PAP therapy and about six months later, including patient-reported outcome and therapy usage by telemetry readout. The distributions of the CD14/CD16-characterized monocyte subsets as well as the CD4/CD8-characterized effector T cell subsets with regard to their PD-1 and PD-L1 expression were analyzed by flow cytometry from blood samples. Data of 25 patients revealed a significant reconstitution of the monocyte subset distribution and a decrease in PD-L1 expression on pan-monocytes and CD8+ T cells without an association to initial AHI and overweight. The PD-1 expression was still increased on T cell subsets, especially on CD4+ TH17/22 cells. We conclude that PAP therapy might have a rapid effect on the monocyte phenotype and overall PD-L1 expression levels. However, T cell immune alterations especially on TH17/22 cells persist longer, indicating an ongoing disturbance of the adaptive immune system.

Introduction Nasal airway obstruction can play an important role in pathogenesis and treatment of obstructive sleep apnea (OSA). Surgery for nasal obstruction can improve patient-reported OSA outcomes, including snoring and daytime sleepiness, as well as adherence and pressure requirements with continuous positive airway pressure (CPAP) therapy. The aim of this study was to examine whether previous nasal surgery was associated with UAS treatment efficacy. Methods From the ADHERE Registry, propensity score matching generated a cohort of UAS patients with prior nasal surgery including septoplasty, turbinate reduction, polyp removal (NS) and a comparable cohort of UAS patients without prior nasal surgery (WNS). Patients were matched based on demographic variables including pre-operative oral appliance use, prior CPAP use, gender, age, baseline apnea hypopnea index (AHI) and baseline Epworth Sleepiness Score (ESS). Data included demographic variables, therapy outcome measures including AHI, ESS, therapy use, and responder rate. Student’s t-test was used to compare normally distributed numeric data and Fisher’s exact test to compare categorical data. One sided t-tests with non-inferiority margin of 7.5 events/hr for AHI, 2 points for ESS, and 0.5 hr/night for Therapy Use were performed to determine non-inferiority. Results The ADHERE dataset from October 2021 included 169 patients from each cohort were matched for comparison. Reduction in AHI was 21.01 ±17.94 in WNS cohort and 18.39 ± 16.4 after UAS (p=0.162) in NS cohort. Reduction in ESS in WNS cohort was 4.85 ± 4.98 and 4.48 ±5.83 (p=0.528) in NS cohort. Therapy use was similar, 5.67 ± 1.95 in WNS and 5.97 ± 2.06 in NS (p=0.181). Responder rate was also similar in WNS (64.5%) and NS (62.1%) (p=0.735). Conclusion Retrospective analysis of UAS patients with vs without prior nasal surgery did not identify differences in UAS therapy outcomes or adherence. Furthermore, outcomes for patients with nasal surgery were non-inferior to those without. Future prospective studies of UAS candidates with nasal airway obstruction may better determine the role of adjunctive nasal surgery in this population. Support (If Any) Inspire Medical Systems

© 2021 The American Laryngological, Rhinological and Otological Society, Inc.Objectives/Hypothesis: To provide the ADHERE registry Upper Airway Stimulation (UAS) outcomes update, including analyses grouped by body mass index (BMI) and therapy discomfort. Study Design: Prospective observational study. Methods: ADHERE captures UAS outcomes including apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), therapy usage, patient satisfaction, clinician assessment, and safety over a 1-year period. BMI ≤32 kg/m2 (BMI32) and 32 < BMI ≤35 kg/m2 (BMI35) group outcomes were examined. Results: One thousand eight hundred forty-nine patients enrolled in ADHERE, 1,019 reached final visit, 843 completed the visit. Significant changes in AHI (−20.9, P

Botulinum neurotoxin (BoNT) is considered the treatment of choice for various symptoms and diseases such as focal dystonia and focal spasticity. The effects of BoNT on the salivary glands have also been known for years, but their use was limited because of a lack of approval studies. Now the indication of sialorrhea is approved in some countries for incobotulinumtoxinA, such as the USA and Europe, and therapy could also become the treatment of choice. According to the pivotal study, a dose of 100 units of incobotulinumtoxinA, which is divided into the parotid and submandibular glands, is recommended. RimabotulinumtoxinB is approved in the USA only. To define the value of this therapy, we must consider anatomy, physiology, and available therapies. Therapy includes conservative measures such as functional dysphagia therapy, oral or transdermal application of anticholinergics, and, in selected cases, radiotherapy and surgical procedures. A combination of different approaches is optional. On the basis of the evidence and clinical experience, BoNT injections will be the first line of pharmacotherapy for chronic sialorrhea.

OBJECTIVE/HYPOTHESIS The ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA. STUDY DESIGN Cohort Study. METHODS Demographic and sleep study data collection occurred at baseline, implantation visit, post-titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea-Hypopnea Index (AHI) and AHI ≤20 at the 12-month visit. RESULTS The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6-month follow-up and 382 have completed the 12-month follow-up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6-45.0) to 9.5 (IQR, 4.0-18.5); mean, 35.8 ± 15.4 to 14.2 ± 15.0, P

Zungenbewegungsmuster (ZBM) konnen die Ergebnisse der oberen Atemwegsstimulation (UAS) bei der Behandlung der obstruktiven Schlafapnoe (OSA) beeinflussen. Ublicherweise wird nach der Implantation eine Lagekontrolle mithilfe des konventionellen Rontgens durchgefuhrt. Wir erstellten ein mehrdimensionales Rontgenbeurteilungssystem und untersuchten, ob sich zwischen diesen Lagebeurteilungen und den ZBM ein Jahr nach der Implantation Verknupfungen herleiten lassen. Die Studie zu den ZBM und der Rontgenbeurteilung erfolgte an einer deutschen HNO-Klinik als Implantationszentrum. Die ZBM wurden unter bipolarer Elektrodenkonfiguration beurteilt und entsprechend der gangigen Literatur in eine linksseitige (LP), rechtsseitige (RP), bilaterale Protrusion (BP) oder als Mischaktivierung (MA) kategorisiert. In 5 Dimensionen erfolgte die Rontgenbeurteilung: relative Cuff-Lage im Verhaltnis zu Mandibula und Hyoid sowie in ihrer Steilheit im seitlichen Bild sowie die Cuff-Lage anhand der einzelnen Elektroden und zum Stimulationskabel im anterior-posterioren Bild. Diese Analyse wurde durch 3 Rater mit unterschiedlicher medizinischer Ausbildung und Kenntnis hinsichtlich der ZBM durchgefuhrt. Ein Jahr nach der Implantation war bei etwa 60 % der Patienten der Apnoe-Hypopnoe-Index unter 15/h gesunken. Die haufigsten ZBM waren BP und RP (82,9 %). Die Interrater-Variabilitat war bis auf eine Kategorie gut. Bis auf die Korrelation zwischen einem gunstigen ZBM und der Cuff-Lage hinsichtlich der lateralen Position des Stimulationskabels ergaben sich keine relevanten Zusammenhange. Trotz der guten Interrater-Variabilitat und einfachen Anwendbarkeit des vorgeschlagenen Rontgenbeurteilungssystems liesen sich keine Zusammenhange erkennen, die ein ZBM und somit einen moglichen aufwendigen Einstellungsverlauf vorhersagen konnten. Moglicherweise sollte bei der Implantation auf eine Drehung des Cuff geachtet werden, mit lateraler Lage des Stimulationskabels.

ZusammenfassungDie größten Speicheldrüsen sind die paarigen Gl. parotis und Gl. submandibularis. Der erwachsene Mensch produziert 1–1,5 l Speichel am Tag, die er regelmäßig abschluckt. Die häufigste Ursache eines vermehrten Speichelflusses mit einer Ansammlung von Speichel im Mund und Ausfluss (Sialorrhoe) ist eine Störung der Schluckfunktion. Seltener kann die Ursache auch eine vermehrte Speichelsekretion, z. B. medikamentös bedingt, sein. Eine Sialorrhoe beeinträchtigt die Lebensqualität erheblich und ist oft auch sozial stigmatisierend. Die Therapie umfasst konservative Maßnahmen wir die funktionelle Dysphagietherapie, orale oder transdermale Applikation von Anticholinergika sowie, in ausgewählten Fällen, invasive Therapien wie Bestrahlungen und Operationen. Seit 20 Jahren wird auch die lokale Injektion von Botulinumtoxin in die Speicheldrüsen erfolgreich therapeutisch eingesetzt. Durch die Zulassung dieser Therapie durch die europäische Behörde darf diese Maßnahme als Therapie der Wahl bei ausgeprägter, therapieresistenter Sialorrhoe angesehen werden.

ZusammenfassungHypersalivation bezeichnet einen übermäßigen Speichelfluss, der durch insuffiziente orofaziale Fähigkeiten, verminderte zentralnervöse Kontrolle und Koordination oder gestörte Schluckabläufe entstehen kann. Die Aktualisierung der S2k-Leitlinie soll den neuen diagnostischen und therapeutischen Kenntnisstand berücksichtigen.Die Diagnostik- und Therapiemaßnahmen sollten multidisziplinär erfolgen. Schwerpunkte sind die Abklärung von Schluckstörungen mit Speichelaspiration. Hier sind klinische Screeninguntersuchungen und die fiberendoskopische Schluckuntersuchung (FEES) hervorzuheben.Bei fast allen Ursachen sind die schlucktherapeutischen Übungsmaßnahmen zur Aktivierung und zum Erlernen von Kompensationsmechanismen unverzichtbar. Insbesondere bei Kindern mit hypotoner orofazialer Muskulatur sind myofunktionelle Therapiekonzepte indiziert, allerdings ist die Kompetenz zur Mitarbeit entscheidend. Zusätzlich können orale Stimulationsplatten durch die Veränderung der Zungenpositionierung zu einer Symptomreduktion führen. Sinnvolle medikamentöse Therapien sind insbesondere die verschiedenen Applikationsformen von Glycopyrrolat, von denen Sialanar® (Glycopyrronium) als Saft eine Genehmigung zur Behandlung bei Kindern ab 3 Jahren und Jugendlichen erhalten hat. Die Injektion von Botulinumtoxin in die Kopfspeicheldrüsen hat sich als effektive und sichere Behandlungsform mit einer langanhaltenden Speichelreduktion erwiesen. Für Incobotulinumtoxin A ist die Phase III-Studie bei Erwachsenen aktuell abgeschlossen und führte in den USA bereits zur Zulassungserweiterung bei Hypersalivation. Chirurgische Eingriffe der Speicheldrüsen bleiben Einzelfällen vorbehalten. Die Bestrahlung der Speicheldrüsen ist, insbesondere wenn sie in moderner 3-D-konformaler Technik zur Gewebeschonung durchgeführt wird, eine sichere und effektive Therapie. In einer regelhaften Nachsorge sind Therapieeffekte und mögliche Nebenwirkungen zu erfassen; insbesondere bei neurodegenerativen Erkrankungen ist die individuelle Dynamik der Symptomverschlechterung zu berücksichtigen.