0665 Bilateral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea

Abstract Introduction Hypoglossal Nerve Stimulation (HGNS) decreases obstructive sleep apnea (OSA) severity by contracting the tongue and decreasing upper airway collapsibility. This study assessed the safety and effectiveness of a new implantable device that delivers bilateral HGNS: the Genio™ system. Methods The BLAST OSA study (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea), was a prospective, open-label, non-randomized, single arm treatment study conducted at eight centres in three countries (Australia, France, UK). Primary outcomes were the incidence of device-related Serious Adverse Events (SAEs) and change in the Apnea-Hypopnea Index (AHI). The secondary outcome was change in the 4% Oxygen Desaturation Index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring, and device use. Participants were eligible if: 21-75 years old; BMI ≤ 32 kg/m2; obstructive AHI 20-60 events/hr and combined central and mixed AHI < 10 events/hr; no positional OSA; no Complete Concentric Collapse of the soft palate during Drug Induced Sleep Endoscopy; and failed to tolerate or accept Positive Airway Pressure treatments. Results 27 participants were implanted (63% male, aged 55.9±12.0 years, BMI 27.4±3.0 kg/m2). 22 completed the protocol. At 6 months, AHI decreased from 23.7±12.2 to 12.9±10.1 events/hr [p<0.001]; and ODI decreased from 19.1±11.2 to 9.8±6.9 events/hr [p<0.001]. Daytime sleepiness (ESS, p=0.011) and sleep-related quality of life (FOSQ-10, p=0.016) both significantly improved. 91% of participants reported using their device >5 days per week, and 77% used it >5 hours per night. The number of bed partners reporting disruptive snoring decreased from 96% to 35%. No device-related SAE occurred. Conclusion In a targeted population of individuals with moderate-to-severe OSA, the Genio system reduced OSA severity and sleepiness, improved quality of life, and was associated with high adherence and an acceptable safety profile. Support This study trial was funded by Nyxoah S.A. This trial was registered with ClinicalTrials.gov, number NCT03048604.

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Tongue-Based Procedures in Treating Refractory Obstructive Sleep Apnea in Down Syndrome Patients: A Systematic Review and Meta-Analysis

FACE ◽

10.1177/2732501621992447 ◽

2021 ◽

Vol 2 (1) ◽

pp. 65-70

Author(s):

Paul B. Lee ◽

Michael T. Chung ◽

Jared Johnson ◽

Jordyn Lucas ◽

Caitlin R. Priest ◽

...

Keyword(s):

Systematic Review ◽

Obstructive Sleep Apnea ◽

Down Syndrome ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Meta Analysis ◽

Apnea Hypopnea Index ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep

Objective: There is a high prevalence of obstructive sleep apnea (OSA) in pediatric and adult Down Syndrome (DS) patients that is refractory to adenotonsillectomy and continuous positive airway pressure. Newer treatment modalities have emerged with improved outcomes. The objective is to provide an updated systematic review and meta-analysis to analyze the clinical outcomes of OSA in pediatric and adult DS patients with hypoglossal nerve stimulation using Inspire, midline posterior glossectomy plus lingual tonsillectomy (MPG + LT), and combined genioglossus advancement plus radiofrequency (GGS + RF). Methods: A comprehensive literature search of PubMed and Google Scholar was performed followed by a meta-analysis. Studies with preoperative and post-operative Apnea Hypopnea Index (AHI) values were included with patients serving as their own control. Results: Across 5 studies, 56 patients were analyzed. The mean reduction in AHI was statistically significant before vs. after procedure ( P < .001 for hypoglossal nerve stimulation using Inspire with a paired 2-tailed t-test and P = .031 for MPG + LT). Although individual patient AHI values were unavailable in the GGS + RF study, the standard difference in mean AHI was also significant for GGS + RF with P = .001. Device malfunction was the most common complication for Inspire while postoperative bleeding was observed for MPG + LT and nasopharyngeal obstruction and retropalatal collapse were observed for GGS + RF. Conclusion: This review reveals significant improvement in AHI with Inspire, MPG + LT, and GGS + RF for DS patients with refractory OSA. Further investigation is needed for comparison between these 3 therapies.

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Previous Surgery and Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Otolaryngology ◽

10.1177/0194599819856339 ◽

2019 ◽

Vol 161 (5) ◽

pp. 897-903 ◽

Cited By ~ 5

Author(s):

Eric J. Kezirian ◽

Clemens Heiser ◽

Armin Steffen ◽

Maurits Boon ◽

Benedikt Hofauer ◽

...

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Therapy Response ◽

Apnea Hypopnea Index ◽

Previous Surgery ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep

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.

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PD47 Implanted Hypoglossal Nerve Stimulation For Obstructive Sleep Apnea

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462318003124 ◽

2018 ◽

Vol 34 (S1) ◽

pp. 145-145

Author(s):

Juan-Pablo Chalco Orrego ◽

Mar Polo-Desantos ◽

Luis María Sánchez-Gómez ◽

Setefilla Luengo-Matos

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Cochrane Library ◽

Apnea Hypopnea Index ◽

Early Assessment ◽

Hypoglossal Nerve Stimulation ◽

Health Technologies ◽

Obstructive Sleep

Introduction:The hypoglossal nerve stimulation (HNS) produces a tongue protrusion for the treatment of mod-severe obstructive sleep apnea (OSA). It is one of the emerging health technologies prioritized to assess its possible inclusion on the Spanish National Health System. The objective of this study is to evaluate the efficacy and safety of this system in the treatment of OSA.Methods:An early assessment (horizon scanning) was performed. The searched databases were: PubMed, WOS, Tripdatabase, Dynamed, Cochrane Library and ICTRP. Clinical studies of OSA patients treated with HNS published until 01 March 2017 were reviewed. Outcomes considered were: AHI (Apnea Hypopnea Index) ODI (Oxygen Desaturation Index) ESS (Epworth sleepiness scale) and AE (adverse events).Results:Four devices of HNS were founded: Inspire™, HGNS®, Aura6000™, and Nixoah™. We found two randomized controlled trials (RCT). The Inspire™ RCT showed significant results on mean differences on AHI (−16.9, 95% CI −24.7 to −9.0); ODI (−15.1, 95% CI −22.7 to −7.5) and ESS (−4.5, 95% CI −7.5 to −1.4) in 46 patients, after one week of follow-up. The HGNS® RCT showed non-significant differences on AHI (device active 22.1 ± 5.2 vs control 29.7 ± 6.2), ODI (11.4 ± 4.1 vs 19.5 ± 5.2) and ESS (9.8 ± 1.0 vs 14.1 ± 2.5) in 21 patients at 6 months. A systematic review that included 6 cases series (3 with HGNS®, 2 with Inspire™ and 1 with Aura6000™) without device subgroup analysis and 7 cohorts studies (6 with Inspire™ and one with Aura6000™) showed significant differences comparing AHI, ODI and ESS results to before treatment values. Major AE reported from the studies varied from 4 to 4.5%. No study with Nixoah™ was found.Conclusions:Inspire™ seems to be an effective option for OSA patients although the evidence is scarce and of low quality for all HNS devices. It would be necessary further well-designed studies.

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461 Hypoglossal Nerve Stimulation: Effectiveness of Therapy for Treatment of Positional Obstructive Sleep Apnea

SLEEP ◽

10.1093/sleep/zsab072.460 ◽

2021 ◽

Vol 44 (Supplement_2) ◽

pp. A182-A182

Author(s):

Michelle White ◽

Elena Stuewe ◽

Rajesh Zacharias ◽

Aarti Grover ◽

Richard Wein

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Supine Position ◽

Hypoglossal Nerve ◽

Apnea Hypopnea Index ◽

Hypoglossal Nerve Stimulation ◽

Persistent Symptoms ◽

Obstructive Sleep ◽

Post Implantation

Abstract Introduction Hypoglossal nerve stimulation (HGNS) therapy is highly effective treatment for patients with moderate-severe obstructive sleep apnea (OSA). Positional OSA is considered when the apnea-hypopnea index (AHI) is at least twice as high in supine position compared with non-supine position. There are few studies in the literature investigating response to HGNS in patients with positional OSA. Methods Pre- and post-implant polysomnography (PSG) data was retrospectively reviewed in 46 patients who underwent HGNS at a large tertiary care center from November 2017 to March 2020. Supine and non-supine AHI were used to diagnose positional OSA on pre- and post-implant PSG. Pre-implant AHI was recorded from both in-lab PSG as well as home sleep tests, while post-implant AHI was based on in-lab hypoglossal nerve stimulator titration performed three months after device activation. Overall AHI pre- and post-implantation and absolute AHI reduction (pre-implant AHI – post-implant AHI) were evaluated. Basic demographic information including age, sex and BMI were also recorded. Results 25/46 patients (54%) were diagnosed with positional OSA on pre-implant PSG. Patients with positional OSA had lower pre-implant overall AHI than patients without positional OSA (AHI 29.6 and 38.9, respectively, p<0.05) and lower absolute AHI reduction than patients without positional OSA (18.2 and 26.7, respectively, p<0.05). There were no statistically significant differences in BMI and post-implant overall AHI between these groups. 19/25 patients (76%) with pre-implant positional OSA had persistent positional OSA on post-implant PSG. Conclusion Patients with positional OSA prior to HGNS had lower pre-implant overall AHI and absolute AHI reduction than patients without positional OSA. However, post-implant overall AHI was comparable, suggesting similar benefit in HGNS therapy regardless of positional OSA diagnosis. HGNS does not appear to resolve positional OSA, given that 76% of patients with positional OSA pre-implantation had persistent positional OSA post-implantation. Positional OSA after HGNS should be recognized in patients with persistent symptoms or inability to tolerate higher device amplitudes, and treatment with combination therapy with positional device can be considered. Support (if any):

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Clinical Radiographic Predictors of Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Otolaryngology ◽

10.1177/0194599820963141 ◽

2020 ◽

pp. 019459982096314

Author(s):

Clara H. Lee ◽

Everett G. Seay ◽

James W. Reese ◽

Xin Wu ◽

Richard J. Schwab ◽

...

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Soft Palate ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Categorical Variables ◽

Apnea Hypopnea Index ◽

Hypoglossal Nerve Stimulation ◽

Index Reduction ◽

Obstructive Sleep

Objective To determine if clinically acquired cephalometric measurements, specifically soft palate size, can predict hypoglossal nerve stimulation outcomes. Study Design Combined prospective cohort study and retrospective review. Setting US sleep otolaryngology training program. Methods Adults with obstructive sleep apnea and apneahypopnea index greater than 15 events/h who underwent hypoglossal nerve stimulation. Eligible subjects had diagnostic preoperative sleep studies and full-night efficacy postoperative studies for analysis. Lateral neck x-rays were obtained as part of routine clinical care and measured for key cephalometric variables by trained head and neck radiologists. Continuous variables were compared using the Student t test, while χ2 testing was used for categorical variables. Results Fifty-one patients met all study criteria. On average, patients were white, middle aged, and overweight. Following hypoglossal nerve stimulation, the overall cohort achieved a significant apnea-hypopnea index reduction from 36.7 events/h to 20.6 events/h ( P < .01) and a response rate of 47% (defined as apnea-hypopnea index reduction >50% and apnea-hypopnea index <20 events/h). On average, therapy responders had significantly thinner soft palates than nonresponders (13.4 ± 3.8 mm vs 16.0 ± 3.4 mm, P = .045). Conclusions Patient-specific anatomic factors, specifically soft palate thickness, may help identify optimal candidates for hypoglossal nerve stimulation. A larger, prospective study including both anatomic and physiologic variables is required to validate these findings.

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Contralateral Tongue Muscle Activation during Hypoglossal Nerve Stimulation

Otolaryngology ◽

10.1177/0194599820917147 ◽

2020 ◽

Vol 162 (6) ◽

pp. 985-992 ◽

Cited By ~ 1

Author(s):

Joshua J. Sturm ◽

Oleg Modik ◽

Ioannis Koutsourelakis ◽

Maria V. Suurna

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Muscle Activation ◽

Hypoglossal Nerve ◽

Oxygen Desaturation ◽

Apnea Hypopnea Index ◽

Hypoglossal Nerve Stimulation ◽

Tongue Muscle ◽

Obstructive Sleep

Objective The effectiveness of upper airway stimulation via hypoglossal nerve stimulation for obstructive sleep apnea depends upon the pattern of tongue muscle activation produced. This study investigated the nature of contralateral tongue muscle activation by unilateral hypoglossal nerve stimulation using intraoperative nerve integrity monitoring in conjunction with electromyography and explored the relationship between contralateral tongue muscle activation and polysomnographic measures of obstructive sleep apnea severity. Study Design Prospective case series. Setting Tertiary care medical center. Subjects and Methods Fifty-one patients underwent unilateral (right) hypoglossal nerve stimulator implantation for obstructive sleep apnea. Neurophysiological data included electromyographic responses in ipsilateral (right) and contralateral (left) genioglossus muscles in response to intraoperative bipolar probe stimulation (0.3 mA) of medial hypoglossal nerve branches. Clinical data included pre- and postoperative apnea-hypopnea indices and oxygen desaturation levels. Results A subset of patients (20/51, 39%) exhibited electromyographic responses in both the ipsilateral and contralateral genioglossus (bilateral), whereas the remaining patients (31/51, 61%) exhibited electromyographic responses only in the ipsilateral genioglossus (unilateral). The baseline characteristics of bilateral and unilateral responders were similar. Both groups exhibited significant and comparable improvements in apnea-hypopnea index and oxygen desaturations after hypoglossal nerve stimulation. Neither the amplitude nor the latency of contralateral genioglossus responses was predictive of clinical outcomes. Conclusion A subset of patients undergoing unilateral hypoglossal nerve stimulation exhibits activation of contralateral genioglossus muscles. Patients with unilateral and bilateral genioglossus responses exhibit comparable, robust improvements in apnea-hypopnea index and oxygen desaturation levels.

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Hypoglossal Nerve Stimulation Usage by Therapy Nonresponders

Otolaryngology ◽

10.1177/01945998211036867 ◽

2021 ◽

pp. 019459982110368

Author(s):

Kimberly K. Coca ◽

Clemens Heiser ◽

Colin Huntley ◽

Maurits Boon ◽

Nico de Vries ◽

...

Keyword(s):

Quality Of Life ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Apnea Hypopnea Index ◽

Long Term Effects ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep ◽

International Multicenter

Objective The purpose of this study is to examine differences in therapy usage and outcomes of therapy between responder (R) and nonresponder (NR) groups in an international, multicenter prospective registry of patients undergoing hypoglossal nerve stimulation for obstructive sleep apnea (OSA). Study Design Database analysis (level III). Setting International, multicenter registry. Methods The studied registry prospectively collects data pre- and postimplantation, including sleep parameters, Epworth score, patient experience, and safety questions, over the course of 12 months. Patients are defined as a “responder” based on Sher criteria, which require a final apnea-hypopnea index (AHI) of ≤20 and a final AHI reduction of >50% at their 12-month follow-up. Results Overall, there were 497 (69%) R and 220 (31%) NR. Most patients in both groups experienced improvement in quality of life following implantation (96% of R; 77% of NR) with reductions in oxygen desaturation index and Epworth score. At final follow-up, the R group demonstrated significantly better adherence to recommended therapy (>4 hours/night) (P = .001), average hours of nightly use (P = .001), final Epworth scores (P = .001), and degree of subjective improvement (P < .001). Conclusion Patients classified as NR to upper airway stimulation continue to use therapy with improvement in percent time of sleep with O2 <90%, reduction in daytime sleepiness, and improvement in quality of life. Therefore, ongoing usage of the device should be encouraged in NR patients who note improvement while integrating additional strategies to lower the long-term effects of OSA.

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Hypoglossal Nerve Stimulation Therapy for the Treatment of Obstructive Sleep Apnea

Neurotherapeutics ◽

10.1007/s13311-021-01012-x ◽

2021 ◽

Cited By ~ 1

Author(s):

Michael D. Olson ◽

Mithri R. Junna

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep

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Voice Disorders in Obstructive Sleep Apnea: Prevalence, Risk Factors, and the Role of CPAP

Annals of Otology Rhinology & Laryngology ◽

10.1177/0003489418819541 ◽

2018 ◽

Vol 128 (3) ◽

pp. 249-262 ◽

Cited By ~ 2

Author(s):

Nelson Roy ◽

Ray M. Merrill ◽

Jenny Pierce ◽

Krishna M. Sundar

Keyword(s):

Quality Of Life ◽

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Voice Disorders ◽

Acid Reflux ◽

Voice Disorder ◽

Apnea Hypopnea Index ◽

Obstructive Sleep ◽

A Current

Objective: Obstructive sleep apnea (OSA) is characterized by frequent interruptions in breathing related to upper airway collapse during sleep and may adversely affect phonatory function. This study aimed to: (1) establish the prevalence, risks, and quality of life burden of voice disorders in OSA and (2) explore the relation between voice disorders and positive airway pressure (PAP) therapy. Study Design: Cross-sectional, descriptive epidemiology study. Methods: Analyses were based on 94 individuals with OSA (53 men, 41 women; mean age = 54.7 ± 12.8 years) who completed a telephone interview. Results: Twenty-eight percent of participants reported having a current voice disorder. Of those with a current voice disorder, 83% had experienced symptoms for at least a year, and 58% had symptoms for at least 4 years. The prevalence of a current voice disorder was greater in women than men (44% vs 15%, P = .0020) but did not vary significantly across different age groups, body mass index (BMI), apnea/hypopnea index (AHI) severity, or medical history. After adjusting for sex, consistent use of PAP therapy (with humidification) was associated with (1) lower occurrence of voice disorders in women (Mantel-Haenszel [MH] χ2 P = .0195), (2) reduced snoring severity accompanied by fewer voice disorders in men (MH χ2 P = .0101), and (3) fewer reports of acid reflux as a possible trigger for voice problems (MH χ2 P = .0226). Patients with OSA who also had a current voice disorder experienced lower overall quality of life compared to those without. Conclusions: Chronic, longstanding voice disorders are common in women with OSA and produce significant adverse effects on quality of life. Nightly PAP use (with humidification) was associated with fewer voice symptoms and reduced severity of snoring and acid reflux as possible contributors. Further research is necessary to better understand the origin of these voice disorders in OSA and their potential response to treatment.

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