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.

Project description:BackgroundHypoglossal nerve stimulation (HNS) with Inspire is a novel treatment indicated for moderate or severe obstructive sleep apnoea/hypopnoea syndrome (OSAHS), intolerant to or unable to be treated with continuous positive airway pressure (CPAP).ObjectiveThe aim of this study was to assess the cost effectiveness of treating moderate or severe OSAHS, in patients intolerant to CPAP, with HNS, compared with standard care, from a National Health Service (NHS) perspective.MethodsA cohort state transition model was developed to compare HNS with Inspire with no treatment in UK adult patients with moderate or severe OSAHS who have previously tried and have not responded to CPAP therapy. Published literature was applied in the model to estimate incremental cost-effectiveness ratios (ICERs; 2019 Great British pounds per quality-adjusted life-year [QALY] gained), from an NHS and personal social services (PSS) perspective, over a cohort's lifetime.ResultsThe model base-case predicts that patients undergoing HNS will incur lifetime costs of £65,026 compared with £36,727 among untreated patients. The HNS cohort would gain 12.72 QALYs compared with 11.15 QALYs in the no-treatment arm. The ICER of treating severe OSAHS with HNS is therefore estimated to be £17,989 per QALYs gained. Probabilistic sensitivity analysis found that at a threshold of £30,000/QALY, HNS has a 69% probability of being cost effective. Limitations of the model include uncertainty around the utility data that were not sourced directly from HNS clinical trials. There is further uncertainty in the relationship between change in the Apnoea-Hypopnoea Index (AHI) and reduction in ischaemic heart disease and stroke because of difficulty capturing the reduction in risk over a long time horizon in studies.ConclusionsOver a patient's lifetime, HNS with Inspire is expected to be cost effective when compared with no treatment in patients with severe OSAHS who have tried and have not responded to CPAP, from an NHS perspective.

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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