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Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes.

ABSTRACT: Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnea pathogenesis. Hypoglossal nerve stimulation activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce obstructive sleep apnea severity. The objective of this study was to examine the safety, feasibility and efficacy of a novel hypoglossal nerve stimulation system (HGNS; Apnex Medical, St Paul, MN, USA) in treating obstructive sleep apnea at 12 months following implantation. Thirty-one subjects (35% female, age 52.4 ± 9.4 years) with moderate to severe obstructive sleep apnea and unable to tolerate positive airway pressure underwent surgical implantation and activation of the hypoglossal nerve stimulation system in a prospective single-arm interventional trial. Primary outcomes were changes in obstructive sleep apnea severity (apnea-hypopnea index, from in-laboratory polysomnogram) and sleep-related quality of life [Functional Outcomes of Sleep Questionnaire (FOSQ)]. Hypoglossal nerve stimulation was used on 86 ± 16% of nights for 5.4 ± 1.4 h per night. There was a significant improvement (P < 0.001) from baseline to 12 months in apnea-hypopnea index (45.4 ± 17.5 to 25.3 ± 20.6 events h(-1) ) and Functional Outcomes of Sleep Questionnaire score (14.2 ± 2.0 to 17.0 ± 2.4), as well as other polysomnogram and symptom measures. Outcomes were stable compared with 6 months following implantation. Three serious device-related adverse events occurred: an infection requiring device removal; and two stimulation lead cuff dislodgements requiring replacement. There were no significant adverse events with onset later than 6 months following implantation. Hypoglossal nerve stimulation demonstrated favourable safety, feasibility and efficacy.

SUBMITTER: Kezirian EJ

PROVIDER: S-EPMC4323268 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes.

Kezirian Eric J EJ Goding George S GS Malhotra Atul A O'Donoghue Fergal J FJ Zammit Gary G Wheatley John R JR Catcheside Peter G PG Smith Philip L PL Schwartz Alan R AR Walsh Jennifer H JH Maddison Kathleen J KJ Claman David M DM Huntley Tod T Park Steven Y SY Campbell Matthew C MC Palme Carsten E CE Iber Conrad C Eastwood Peter R PR Hillman David R DR Barnes Maree M

Journal of sleep research 20130904 1

Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnea pathogenesis. Hypoglossal nerve stimulation activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce obstructive sleep apnea severity. The objective of this study was to examine the safety, feasibility and efficacy of a novel hypoglossal nerve stimulation system (HGNS; Apnex Medical, St Paul, MN, USA) in treating obstructive sleep apnea at 12 months followi ...[more]

PMID: 24033656

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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:ImportanceEvidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA).ObjectiveTo evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA.Design, setting, and participantsThis randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less. The trial was conducted from May 2015 through June 2018. Data were analyzed from January 2022 through January 2023.InterventionImplant with THN system; randomized 2:1 to activation at month 1 (treatment) or month 4 (control). All received 11 months of THN with follow-up at months 12 and 15, respectively.Main outcomes and measuresPrimary effectiveness end points comprised AHI and oxygen desaturation index (ODI) responder rates (RRs). Treatment responses at months 4 and 12/15 were defined as a 50% or greater reduction in AHI to 20 or less per hour and an ODI decrease of 25% or greater. Coprimary end points comprised (1) month 4 AHI and ODI RR in the treatment greater than the control group and (2) month 12/15 AHI and ODI RR in the entire cohort exceeding 50%. Secondary end points included sleep apnea severity (AHI and ODI) and patient-reported outcomes (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale).ResultsAmong 138 participants, the mean (SD) age was 56 (9) years, and 19 (13.8%) were women. Month 4 THN RRs were substantially greater in those in the treatment vs control group (AHI, 52.3% vs 19.6%; ODI, 62.5% vs 41.3%, respectively) with treatment-control standardized mean differences of 0.725 (95% CI, 0.360-1.163) and 0.434 (95% CI, 0.070-0.843) for AHI and ODI RRs, respectively. Months 12/15 RRs were 42.5% and 60.4% for AHI and ODI, respectively. Improvements in AHI, ODI, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale scores were all clinically meaningful (medium to large effect size). Two serious adverse events and 100 nonserious related adverse events were observed from the implant procedure or study protocol.Conclusions and relevanceThis randomized clinical trial found that THN demonstrated improvements in sleep apnea, sleepiness, and quality of life in patients with OSAs over an extended AHI and body mass index range without prior knowledge of pharyngeal collapse pattern. Clinically meaningful improvements in AHI and patient-reported responses compared favorably with those of distal hypoglossal nerve stimulation trials, although clinically meaningful differences were not definitive for ODI.Trial registrationClinicalTrials.gov Identifier: NCT02263859.

Project description:Study objectivesData on adherence and outcome of upper airway stimulation (UAS) for patients with obstructive sleep apnea (OSA) are collected in an international registry (ADHERE). Previous publications report significant improvement in self-reported and objective OSA outcomes, durable effectiveness, and high adherence. Debate remains whether the effectiveness of UAS is influenced by preoperative OSA severity; therefore, we aimed to evaluate this using data from the ADHERE Registry.MethodsADHERE is a postmarket, ongoing, international multicenter registry. Adult patients were included if they had undergone UAS implantation and had at least 1 follow-up visit recorded in the database on June 8, 2021. We divided the patients into 5 subgroups, based on OSA severity at baseline (AHI in events/h): subgroup 1 (0-15), 2 (15-30), 3 (≥ 30-50), 4 (> 50-65), and 5 (> 65). We compared results regarding objective and self-reported treatment outcomes.ResultsA total of 1,963 patients were included. Twelve months after implantation, there was a significant (P < .0001) improvement in objective sleep parameters in all subgroups with an AHI above 15 events/h. Patients in subgroup 1 had the lowest AHI at the final visit and the AHI reduction in patients in subgroup 5 was the largest (P < .0001). No significant difference was found between the subgroups in overall treatment success (66.6%) and improvement in self-reported outcomes.ConclusionsOur results suggest that UAS is an effective treatment for patients with an AHI ≥ 15 events/h, independent of preoperative OSA severity. Self-reported outcomes and treatment success did not differ significantly between the 5 subgroups. These results clearly support that the indication of UAS could be broadened for patients with an AHI above 65 events/h, which, to date, is not common practice.Clinical trial registrationRegistry: ClinicalTrials.gov; Title: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry (ADHERE Registry); Identifier: NCT02907398; URL: https://www.clinicaltrials.gov/ct2/show/NCT02907398.CitationBosschieter PFN, de Vries N, Mehra R, et al. Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease severity categories. J Clin Sleep Med. 2022;18(6):1657-1665.

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Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes.

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Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes.

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