Dataset Information

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.

ABSTRACT: BACKGROUND AND AIM:Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6?months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system. METHODS:This prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea-hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604. RESULTS:22 out of 27 implanted participants (63% male, aged 55.9±12.0?years, body mass index (BMI) 27.4±3.0?kg·m-2) completed the protocol. At 6?months BMI was unchanged (p=0.85); AHI decreased from 23.7±12.2 to 12.9±10.1?events·h-1, a mean change of 10.8?events·h-1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9?events·h-1, a mean change of 9.3?events·h-1 (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5?days per week, and 77% reported use for >5?h per night. No device-related serious adverse events occurred during the 6-month post-implantation period. CONCLUSIONS:Bilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.

SUBMITTER: Eastwood PR

PROVIDER: S-EPMC6949509 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.

Eastwood Peter R PR Barnes Maree M MacKay Stuart G SG Wheatley John R JR Hillman David R DR Nguyên Xuân-Lan XL Lewis Richard R Campbell Matthew C MC Pételle Boris B Walsh Jennifer H JH Jones Andrew C AC Palme Carsten E CE Bizon Alain A Meslier Nicole N Bertolus Chloé C Maddison Kathleen J KJ Laccourreye Laurent L Raux Guillaume G Denoncin Katleen K Attali Valérie V Gagnadoux Frédéric F Launois Sandrine H SH

The European respiratory journal 20200109 1

<h4>Background and aim</h4>Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity <i>via</i> genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS <i>via</i> a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system.<h4>Methods</h4>This prospective, open-label, non-randomised, single-arm ...[more]

PMID: 31601716

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Project description:ImportanceHypoglossal nerve stimulation is a treatment option for patients with obstructive sleep apnea unable to tolerate continuous positive airway pressure. This study evaluates demographic factors that may be associated with greater improvements in postoperative outcomes of interest.ObjectiveTo examine the association of hypoglossal nerve stimulation with obstructive sleep apnea severity, daytime sleepiness, and sleep-related quality of life.Design, setting, and participantsPatient-level data were pooled from 3 prospective cohorts and 1 retrospective observational cohort comprising 584 adults with moderate to severe obstructive sleep apnea unable to tolerate or benefit from continuous positive airway pressure. The data were gathered from the Stimulation Therapy for Apnea Reduction Trial; a postmarket approval study conducted in Germany; the multicenter, international Adherence and Outcome of Upper Airway Stimulation for OSA Registry; and a retrospective cohort study from 2 sites in the United States.ExposureHypoglossal nerve stimulation.Main outcomes and measuresSeverity of obstructive sleep apnea was the primary outcome. The apnea-hypopnea index (AHI) (<5, normal; 5-15, mild; 15-30, moderate, and >30, severe) and Epworth Sleepiness Scale (range, 0-24; score >10 indicates pathologic sleepiness) outcomes were available at 2 to 6 months from 2 cohorts (n = 398), at 12 months from 1 cohort (n = 126), and at both times from 1 cohort (n = 60). Sleep-related quality of life and oxygen saturation nadir data were collected where available. Linear mixed-effects models were constructed to examine associations between clinical variables and reported postoperative outcomes at 6 and 12 months with study included as a random effect.ResultsOf the 584 patients included in the study, 472 were men (80.8%); mean (SD) age was 58.5 (11.0) years. Greater improvement in the postoperative AHI was associated with a higher preoperative AHI (-0.74 events/h; 95% CI, -0.82 to -0.67), older patient age (-0.10 events/h; 95% CI, -0.20 to -0.00), and lower body mass index (0.52; 95% CI, 0.22-0.83). After adjusting for these variables and considering all patients in the analysis, the AHI was statistically higher at 12 months than at 6 months (3.24 events/h; 95% CI, 1.67-4.82 events/h).Conclusions and relevanceHypoglossal nerve stimulation demonstrated clinically significant improvements in obstructive sleep apnea severity, daytime sleepiness, and sleep-related quality of life in this pooled cohort of patient-level results. Age, body mass index, and preoperative AHI appeared to be associated with treatment outcomes, and these variables may explain some of the difference between 2- to 6-month and 12-month outcomes.

Dataset Information

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.

Publications

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.

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