Bilateral vs Unilateral Hypoglossal Nerve Stimulation in Patients With Obstructive Sleep Apnea.

Objective: Unilateral hypoglossal nerve stimulation (uniHNS) is an effective treatment for obstructive sleep apnea. Bilateral hypoglossal nerve stimulation (biHNS) is a novel therapeutic option and a different approach to hypoglossal nerve stimulation. The aim of this study was to analyze the clinical outcome of the first 10 biHNS cases vs the first 10 uniHNS cases ever implanted. Study Design: Prospective data analysis. Setting: International multicenter comparative clinical trial. Methods: The first 10 patients in 2020 who received a biHNS device (Genio System; Nyxoah) and the first 10 patients in 2014 who received a uniHNS system (Inspire II; Inspire Medical Systems) were included. Treatment outcome was evaluated at 3 months after surgery. Data collection included demographics, apnea hypopnea index (AHI), oxygen saturation and desaturation index, Epworth Sleepiness Scale, and adverse events. Results: The mean ± SD age was 52.1 ± 9.6 years (biHNS) and 58.3 ± 8.6 years (uniHNS). The mean body mass index was 26.4 ± 5.6 kg/m2 (biHNS) and 26.2 ± 2.2 kg/m2 (uniHNS). The mean preimplantation AHI (biHNS, 39.9 ± 14.8/h; uniHNS, 32.2 ± 11.0/h) decreased in both groups after 3 months (biHNS, 19.2 ± 14.0/h, P = .008; uniHNS, 13.1 ± 16.8/h, P = .037) with no significant difference between groups (P = .720). The mean preimplantation Epworth Sleepiness Scale (biHNS, 11.8 ± 6.2; uniHNS, 11.1 ± 4.9) decreased as well after 3 months (biHNS, 9.4 ± 6.3; uniHNS, 6.0 ± 5.0). Conclusion: Preliminary postmarket data suggest that biHNS may be as safe and effective as uniHNS. Long-term follow-up in a larger sample size is required to assess the stability of biHNS.

The relationship between obstructive sleep apnea with hearing and balance: A scoping review.

BACKGROUND: Obstructive sleep apnea (OSA) has been linked to multiple co-morbidities, and some research points to a potential relationship between OSA and hearing and balance dysfunction, and the benefits of continuous positive airway pressure (CPAP) treatment. OBJECTIVE: The present study was undertaken as a scoping review of research on OSA and its impact on hearing and balance function in adults and children and whether the treatment of CPAP would affect hearing and balance function. METHOD: Online databases were used to identify 45 papers published that used hearing and balance assessments concerning OSA and CPAP therapy as a primary outcome. The secondary outcome was the subjective perception through validated questionnaires. RESULTS: Whilst the data on the effect of OSA on middle ear function remains inconclusive, most papers demonstrate an increase in hearing thresholds, an absence of otoacoustic emissions (OAE) and delayed auditory brainstem response (ABR) in adults with OSA. Nystagmus and abnormal vestibular evoked myogenic potentials (VEMPs) were observed in the small number of papers. The positive pressure from CPAP significantly and transiently increases middle ear pressure, however, its effects on other auditory regions and the vestibular system remains inconclusive. Research on hearing and balance function in children with OSA is limited. CONCLUSIONS: Narrow assessments of hearing and balance are not sufficient to understand the nature of hearing and balance function in OSA patients and the effect of CPAP therapy. More comprehensive assessments are necessary to observe peripheral and central changes in the auditory and vestibular pathways.

Sleep position, patient comfort, and technical performance with two established procedures for home sleep testing.

PURPOSE: In patients with a high pre-test probability of suffering from obstructive sleep apnea (OSA), (cardio)-respiratory polygraphy (RP; level 3) is commonly used for home sleep testing (HST); however, testing based on peripheral arterial tonometry (PAT) is increasingly recognized as an alternative method. The aim of the study was to compare sleep position, patients' comfort, and technical failure rates of HST with RP and PAT in patients with suspected OSA. METHODS: Sleep position, patients' comfort, and technical failure rates of RP and PAT were compared in 56 patients receiving two nights of HST with either RP or PAT in a randomized fashion. RESULTS: Time in supine position with PAT was significantly lower (173.7±88 min) compared to RP (181.7±103.7 min; p < 0.001), although the absolute mean difference was not clinically significant. Patients reported to sleep better, feeling less disturbed when falling asleep, losing less sensors, and fewer nightly awakenings with PAT, but experienced more pain at the side of the finger probe. Forty-five out of 56 patients (80%) rated PAT as being the superior sleep test and 49 out of 56 (88%) would prefer PAT for further investigations (p<0.001). PAT testing was associated with less technical failures. CONCLUSION: The results demonstrate that HST with PAT leads to less time in supine sleep positioning, which may be clinically relevant in selected patients. Moreover, PAT is associated with less technical failures and is perceived with less discomfort during testing and a reduced number of nocturnal awakenings in patient self-reports.

Maximum isometric tongue force in patients with obstructive sleep apnoea.

BACKGROUND: Obstructive sleep apnea (OSA) is a sleep disorder with a prevalence of 9-38%. The underlying pathology in OSA is a collapse of the upper airway. Especially in more severely affected patients, this collapse is often located at the level of the tongue base. Therefore, various implantable systems (anchors and ligament techniques) were developed to prevent or overcome this collapse. These systems are exposed to various forces. Different models have been developed to measure these forces and data comparing forces in healthy individuals with OSA patients are rare. PURPOSE: Purpose of the study was to evaluate possible differences in tongue forces between healthy individuals and patients with OSA. METHOD: To evaluate maximum isometric tongue forces, we conducted a matched pair design study including 20 healthy individuals and 20 patients suffering from OSA. Maximum isometric tongue forces were measured in an anterior/posterior direction with the help of self-designed new device that clamps the tongue. RESULTS: We could show that the maximum isometric force does not differ significantly in healthy individuals (10.7 ± 5.2N) from patients with OSA (14.4 ± 6.3N). CONCLUSION: Currently there are no indications that maximum isometric tongue force does differ in healthy individuals and patients with OSA. Higher, as well as lower, tongue forces in patients with OSA seem not to differ from healthy subjects and therefore may not be needed to consider, in the development of tongue management devices, for OSA patients.

Cocaine Reduces Ciliary Beat Frequency of Human Nasal Epithelial Cells.

BACKGROUND/AIM: Cocaine is a widely used recreational drug and is known for its nasal complications including epithelial, cartilage and bone damage. The aim of the study was to analyze the impact of cocaine on ciliary beat frequency (CBF) of human nasal epithelial cells and therefore better understand its side effects on nasal mucosa. MATERIALS AND METHODS: Nasal epithelial cells of 21 healthy subjects were harvested and exposed in vitro to cocaine hydrochloride solutions ranging from 0.875% to 7%. High-speed video footage was acquired with phase contrast microscopy and CBF was analyzed with Sissons-Ammons Video Analysis (SAVA) software. RESULTS: All tested concentrations led to a significant reduction in CBF compared to the control. Effects increased over time and with concentration. A mechanical inhibition of cilia by cocaine crystals was also observed. CONCLUSION: We assume that CBF reduction is part of the pathomechanism leading to nasal complications in cocaine abuse. Considering these results, clinical usage of cocaine should be critically evaluated and restricted to select cases only.

Apoptosis-related Proteins Are Altered by Selective Tyrosine Kinase Inhibitors and Everolimus in HPV-dependent SCC.

BACKGROUND: Head and neck squamous cell cancer (HNSCC) affects the oral cavity and the pharynx. The aim of the study was to investigate the effects of selective tyrosine kinase inhibitors (TKIs) erlotinib, gefitinib, nilotinib and dasatinib and the mammalian target of rapamycin (mTOR) inhibitor everolimus on the expression of apoptosis-related proteins caspase-3, FAS cluster of differentiation (CD)-95 and FAS ligand in human papilloma virus (HPV)-dependent squamous cancer. MATERIALS AND METHODS: Two HPV-negative cell lines (UMSCC-11A/-14C) and one HPV-positive cell line (CERV196) were incubated with TKIs or everolimus and protein concentrations of target proteins were analyzed with enzyme-linked immunosorbent assay (ELISA). RESULTS: Caspase-3 was affected by the tested TKIs in HPV-positive SCC, whereas FAS CD95 and FAS ligand were influenced in HPV-negative SCC. DISCUSSION: This is the first study to analyze the influence of TKIs and everolimus on key proteins of apoptosis. Our results provide novel information contributing to a better understanding of the cell biology of HPV-dependent HNSCC and might contribute to the discovery of novel pharmaceutical treatment strategies for HNSCC.

Changes in breath cycle sensing affect outcomes in upper airway stimulation in sleep apnea.

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.

Reflex swallowing elicited by electrical stimulation in obstructive sleep apnea patients: A preliminary study.

This study tested whether electrical stimulation of the pharyngeal mucosa is able to induce reliably the swallowing reflex in awake and asleep obstructive sleep apnea (OSA) patients, and whether the induced reflexes affect the sleep variables. In addition, the latency, occurrence, and morphology of swallows were evaluated. Eight patients received an esophageal catheter that was used on three consecutive nights for electrical stimulation and manometric recordings. The electrical stimulation proved itself safe, but its efficiency in inducing swallows sank from 80.0 % in awake to 37.4 % in sleeping subjects and was lowest in the sleep stage N3. The swallowing reflex was triggered with a mean latency of 3.69 ± 0.70 s, was predominantly induced in the hyperventilation phase, and had no significant effect on the subject's sleep variables. These findings indicate that electrical stimulation can more effectively trigger the swallowing reflex while the subjects are awake than during sleep without showing remarkable clinical benefits in terms of apnea-hypopnea index (AHI) improvement.

Previous Surgery and Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea.

OBJECTIVE: To examine whether previous palate or hypopharyngeal surgery was associated with efficacy of treatment of obstructive sleep apnea with hypoglossal nerve stimulation. STUDY DESIGN: Cohort (retrospective and prospective). SETTING: Eleven academic medical centers. SUBJECTS AND METHODS: Adults treated with hypoglossal nerve stimulation were enrolled in the ADHERE Registry. Outcomes were defined by the apnea-hypopnea index (AHI), in 3 ways: change in the AHI and 2 definitions of therapy response requiring ≥50% reduction in the AHI to a level <20 events/h (Response20) or 15 events/h (Response15). Previous palate and hypopharyngeal (tongue, epiglottis, or maxillofacial) procedures were documented. Linear and logistic regression examined the association between previous palate or hypopharyngeal surgery and outcomes, with adjustment for age, sex, and body mass index. RESULTS: The majority (73%, 217 of 299) had no previous palate or hypopharyngeal surgery, while 25% and 9% had previous palate or hypopharyngeal surgery, respectively, including 6% with previous palate and hypopharyngeal surgery. Baseline AHI (36.0 ± 15.6 events/h) decreased to 12.0 ± 13.3 at therapy titration (P < .001) and 11.4 ± 12.6 at final follow-up (P < .001). Any previous surgery, previous palate surgery, and previous hypopharyngeal surgery were not clearly associated with treatment response; for example, any previous surgery was associated with a 0.69 (95% CI: 0.37, 1.27) odds of response (Response20 measure) at therapy titration and a 0.55 (95% CI: 0.22, 1.34) odds of response (Response20 measure) at final follow-up. CONCLUSION: Previous upper airway surgery was not clearly associated with efficacy of hypoglossal nerve stimulation.

Implantation of the nyxoah bilateral hypoglossal nerve stimulator for obstructive sleep apnea.

OBJECTIVES: This report describes the surgical implantation of a novel bilateral hypoglossal nerve stimulator (Genio system®, Nyxoah S.A., Belgium) and the successful treatment of a patient with moderate obstructive sleep apnea (OSA). STUDY DESIGN: Surgical technique description and case study report. METHODS: The bilateral implantable stimulator (IS) simultaneously stimulates both genioglossus (GG) muscles to reduce airway obstruction. At night, patients wear an activation chip under their chin that wirelessly transmits energy to the implant and enables the nerve stimulation. Surgical implantation of the IS is performed under general anesthesia by making a small incision above the hyoid bone and dissecting through the platysma, mylohyoid, and geniohyoid muscles to the GG muscle. The hypoglossal nerve branches are then identified, followed by suturing the IS in place. The system was evaluated in an otherwise healthy, 60-year-old woman with moderate OSA (apnea hypopnea index (AHI): 25/hr, nadir O2 saturation: 78%). Appropriate stimulation settings were determined at 2-, 3-, and 6-months post implantation during polysomnography (PSG) and changes in apnea and hypopnea events and oxygen desaturation recorded. RESULTS: The surgery was well tolerated by the patient with an uneventful recovery. The PSG at 6 months showed that AHI per hour, obstructive apnea events per hour, hypopnea events per hour, and oxygen desaturation index have been reduced by 88%, 92%, 88%, and 97%, respectively, and nadir O2 saturation improved to 91%. CONCLUSIONS: The absence of complications and considerable reduction of apnea and hypopnea events in this case study help demonstrate the potential safety and efficacy of the bilateral hypoglossal nerve stimulator. LEVEL OF EVIDENCE: 4.

Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry.

Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), objective adherence, adverse events and patient satisfaction measures. Post hoc univariate and multiple logistic regression were performed to evaluate factors associated with treatment success.Between October 2016 and January 2018, 508 participants were enrolled from 14 centres. Median AHI was reduced from 34 to 7 events·h-1, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1-unit increase in body mass index (BMI), there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.In a large multicentre international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response.

Uvulopalatopharyngoplasty with or without tonsillectomy in the treatment of adult obstructive sleep apnea - A systematic review.

BACKGROUND: The most commonly performed surgical procedure for obstructive sleep apnea (OSA) is uvulopalatopharyngoplasty with or without tonsillectomy (UPPP ± TE). However, there is currently no review solely focusing on clinically relevant effects of standard UPPP technique with or without tonsillectomy as a monotherapy in patients with OSA. METHODS: A systematic review and meta-analysis were performed to assess the effects of isolated UPPP ± TE in patients with OSA. Studies of any design referring to adult patients with obstructive sleep apnea diagnosed via polysomnography or comparable objective measures were considered, in which isolated "standard" UPPP ± TE was performed. RESULTS: Forty-eight studies were included for the qualitative analysis. All but one study demonstrated a reduction in the frequency of respiratory events and success/response rates ranged from 35 to 95.2%. In the six studies that reported pre- and postoperative mean scores of the Epworth Sleepiness Scale (ESS), a reduction in sleepiness scores was demonstrated. Data addressing the effect of UPPP ± TE in comparison to no treatment or control were available from two randomized controlled trials (RCT). When pooling the data, UPPP ± TE was significantly more effective in reducing the apnea-hypopnea index (AHI) and Epworth Sleepiness Scale (ESS) (large effect): an AHI mean difference (MD) of -18.59 (95% CI -34.14, -3.04) and an ESS MD of -5.37 (95% CI -7,03, -3.72). Data addressing effect of UPPP ± TE in comparison to baseline was available from three RCT. When pooling the data, the AHI was reduced from a mean 35.4 to 17.9 (49.5% reduction); a MD of -20.41, 95% CI -32.78, -8.04 (-1.80, -1.15) (large effect). Various additional beneficial effects of UPPP ± TE were demonstrated including improvement in sexual function, ventricular function, sleep stages, serum lipid, depressive disorder and driving performance. CONCLUSION: UPPP ± TE reduces respiratory events and daytime sleepiness in adult patients with OSA and UPPP ± TE is superior to non-treated controls in this regard. Further research is needed to establish the long-term benefit, the impact on cardiovascular morbidity and the role of UPPP ± TE in the variety of available treatment options for OSA.

Upper Airway Stimulation for Obstructive Sleep Apnea: Results from the ADHERE Registry.

Objective Upper airway stimulation (UAS) is an alternative treatment option for patients unable to tolerate continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA). Studies support the safety and efficacy of this therapy. The aim of this registry is to collect retrospective and prospective objective and subjective outcome measures across multiple institutions in the United States and Germany. To date, it represents the largest cohort of patients studied with this therapy. Study Design Retrospective and prospective registry study. Setting Ten tertiary care hospitals in the United States and Germany. Subjects and Methods Patients were included who had moderate to severe OSA, were intolerant to CPAP, and were undergoing UAS implantation. Baseline demographic and sleep study data were collected. Objective and subjective treatment outcomes, adverse events, and patient and physician satisfaction were reviewed. Results The registry enrolled 301 patients between October 2016 and September 2017. Mean ± SD AHI decreased from 35.6 ± 15.3 to 10.2 ± 12.9 events per hour ( P < .0001), and Epworth Sleepiness Scale scores decreased from 11.9 ± 5.5 to 7.5 ± 4.7 ( P < .0001) from baseline to the posttitration visit. Patients utilized therapy for 6.5 hours per night. There were low rates of procedure- and device-related complications. Clinical global impression scores demonstrated that the majority of physicians (94%) saw improvement in their patients' symptoms with therapy. The majority of patients (90%) were more satisfied with UAS than CPAP. Conclusions Across a multi-institutional registry, UAS therapy demonstrates significant improvement in subjective and objective OSA outcomes, good therapy adherence, and high patient satisfaction.

Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study.

OBJECTIVE/HYPOTHESIS: Upper airway stimulation (UAS) of the hypoglossal nerve has been implemented in the routine clinical practice for patients with moderate-to-severe obstructive sleep apnea (OSA) who could not adhere to continuous positive airway pressure. This study reports objective and patient-reported outcome after 12 months of implantation. STUDY DESIGN: Multicenter prospective single-arm study. METHODS: Consecutive patients who received the UAS system (Inspire Medical Systems, Inc., Minneapolis, Minnesota, Maple Grove, MN, U.S.A.) were enrolled in three German centers. Key study exclusion criteria included body mass index > 35 kg/m2 , apnea-hypopnea index (AHI) < 15 or > 65, or complete concentric collapse at the soft palate during sedated endoscopy. Data collection at 6- and 12-month visit include home sleep test and patient-reported outcome measures. RESULTS: Among the total of 60 participants, the median AHI reduced from 28.6 to 9.5 from baseline to 12 months. Patient-reported outcome measured in Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire both improved significantly from baseline to 12 months. The average usage time was 39.1 ± 14.9 hours per week among all participants based on recordings by the implanted device. One patient requested a removal of the device for cosmetic and other personal reasons and was completed without sequelae. CONCLUSION: This study supported that UAS is a safe and effective treatment option for patients with OSA in routine clinical practice. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:509-515, 2018.

Influence of static magnetic fields on human myoblast/mesenchymal stem cell co­cultures.

The results of surgical repair of extensive muscle tissue defects are still of primary concern, leaving patients with residual cosmetic and functional impairments. Therefore, skeletal muscle tissue engineering attempts to grow functional neo­tissue from human stem cells to promote tissue regeneration and support defect closure. Despite intensive research efforts, the goal of stable induction of myogenic differentiation in expanded human stem cells by using clinically feasible stimuli, has not yet been reached to a sufficient extent. Therefore, the present study investigated the differentiation potential of static magnetic fields (SMFs), using co­cultures of human satellite cells and human mesenchymal stem cells (MSCs). It has previously been demonstrated that SMFs may act as a promising myogenic stimulus. Tests were performed on co­cultures with and without SMF exposure, using growth medium [high growth factor concentrations (GM)] and differentiation medium [low growth factors concentrations (DM)]. AlamarBlue® assay­based cell proliferation analysis revealed no significant difference between co­cultures with, vs. without SMF stimulation, regardless of growth factor concentrations in the cell culture medium. To determine the degree of differentiation in co­cultures under stimulation with SMFs, semi­quantitative gene expression measurements of the following marker genes were performed: Desmin, myogenic factor 5, myogenic differentiation antigen 1, myogenin, adult myosin heavy chain 1 and skeletal muscle α1 actin. In neither GM nor DM was a steady, significant increase in marker gene expression detected. Verifying the gene expression findings, immunohistochemical antibody staining against differentiation markers revealed that SMF exposure did not enhance myogenic maturation. Therefore, SMF treatment of human satellite cell/MSC co­cultures did not result in the desired increase in myogenic differentiation. Further studies are required to identify a suitable stimulus for skeletal muscle tissue engineering.

Heated air humidification versus cold air nebulization in newly tracheostomized patients.

BACKGROUND: After tracheostomy, the airway lacks an essential mechanism for warming and humidifying the inspired air with the consequent functional impairment and discomfort. The purpose of this study was to compare airway hydration with cold-air nebulization versus heated high-flow humidification on medical interventions and tracheal ciliary beat frequency (CBF). METHODS: Newly tracheostomized patients (n = 20) were treated either with cold-air nebulization or heated humidification. The number of required tracheal suctioning procedures to clean the trachea and tracheal CBF were assessed. RESULTS: The number of required suctions per day was significantly lower in the heated humidification group with medians 3 versus 5 times per day. Mean CBF was significantly higher in the heated humidification group (6.36 ± 1.49 Hz) compared to the cold-air nebulization group (3.99 ± 1.39 Hz). CONCLUSION: The data suggest that heated humidification enhanced mucociliary transport leading to a reduced number of required suctioning procedures in the trachea, which may improve postoperative patient care.

Innovative Surgery for Obstructive Sleep Apnea: Nerve Stimulator.

Obstructive sleep apnea (OSA) as a multifactorial disease is treated with continuous positive airway pressure (CPAP) as the gold standard. Yet, if patients suffer from CPAP incompliance, traditional OSA surgery only targets morphological changes of the upper airway while neglecting functional issues. With the advent of upper airway stimulation, and in particular hypoglossal nerve stimulation as a treatment option, a highly effective, clinically proven and functional therapy with good evidence is available. This article gives a comprehensive overview of current and upcoming hypoglossal nerve stimulation systems (Inspire, ImThera, and Nyxoah), the specific advantages of this approach, the selection criteria and screening process, relevant clinical data, and a description of the different implantation procedures. Upper airway stimulation and hypoglossal nerve stimulation appears to be a long-term, low-morbidity treatment for moderate-to-severe OSA patients suffering from CPAP incompliance.

[Handling and reprocessing of semicritical medical devices in the ENT - a prospective study]. / Umgang und Aufbereitung semikritischer Medizinprodukte in der HNO ­ eine prospektive Studie.

Numerous laws, guidelines and recommendations govern the handling and reprocessing of semi-critical medical devices in the field of ENT. Although mechanically reprocessing is characterized as a preferential, manual reprocessing is still conducted in most ENT clinics and medical practices for reasons of cost and practicability. In the presented study, we developed an optimized hygienic concept for reprocessing of medical products in the field of ENT.A demand analysis of rigid endoscopes and of ENT equipment was carried out based on hypothesis that only mechanical reprocessing was performed for the entire instrumentation. Additionally, patient-free activities like preparing instrumentation for examination were investigated. As a result, we could demonstrate that such patient-free activities represent a considerable time factor and as a consequence a cost factor in daily patient care. Necessary investments for only mechanical reprocessing of instrumentation including rigid endoscopes are considerably high, since number of endoscopes have to be kept very high.

Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study.

Objective Selective stimulation of the hypoglossal nerve is a new surgical therapy for obstructive sleep apnea, with proven efficacy in well-designed clinical trials. The aim of the study is to obtain additional safety and efficacy data on the use of selective upper airway stimulation during daily clinical routine. Study Design Prospective single-arm study. Setting Three tertiary hospitals in Germany (Munich, Mannheim, Lübeck). Subjects and Methods A multicenter prospective single-arm study under a common implant and follow-up protocol took place in 3 German centers (Mannheim, Munich, Lübeck). Every patient who received an implant of selective upper airway stimulation was included in this trial (apnea-hypopnea index ≥15/h and ≤65/h and body mass index <35 kg/m2). Before and 6 months after surgery, a 2-night home sleep test was performed. Data regarding the safety and efficacy were collected. Results From July 2014 through October 2015, 60 patients were included. Every subject reported improvement in sleep and daytime symptoms. The average usage time of the system was 42.9 ± 11.9 h/wk. The median apnea-hypopnea index was significantly reduced at 6 months from 28.6/h to 8.3/h. No patient required surgical revision of the implanted system. Conclusion Selective upper airway stimulation is a safe and effective therapy for patients with obstructive sleep apnea and represents a powerful option for its surgical treatment.