Dataset Information

Nerve Stimulation for the Treatment of Obstructive Sleep Apnea.

ABSTRACT:

Purpose

This review will trace the elements of neurostimulation for obstructive sleep apnea and details on its implementation, efficacy and safety, immediate clinical outcomes, and future prospects.

Methods

The literature on upper airway neurostimulation was surveyed from July, 2013, to July 2019, with a focus on the components of devices, evidence for clinical utility, and adverse events.

Results

Current technology is focused on the hypoglossal nerve stimulation (HNS). The most long-term experience is with the Inspire Medical System (Maple Grove, MN USA) which has both FDA and European regulatory approval. Given the inclusion criteria (BMI <35, ideally <32), AHI 15-65/h, and a favorable anterior-posterior velopharyngeal collapse pattern on DISE), across many centers ~65% of patients who are intolerant to primary therapy achieve clinical success (AHI <20/h with a reduction of <50% in AHI), and more have symptomatic relief. Adverse events are generally mild, often self-limited, with occasional need for uncomplicated surgical adjustments or replacement of the implantable generator. Three other devices are in various phases of development, each with a differences in nerve electrodes, implantable components, power sources, proprietary programming, and activation patterns.

Conclusions

HNS is not considered a first-line treatment option. HNS therapy, however, should be considered as one alternative therapeutic option for patients meeting the inclusion criteria when more traditional therapeutic options have been considered.

SUBMITTER: Yamauchi M

PROVIDER: S-EPMC10686243 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

Nerve Stimulation for the Treatment of Obstructive Sleep Apnea.

Yamauchi Motoo M Satoh Makoto M Kitahara Tadashi T Ota Ichiro I Strohl Kingman K

Sleep and biological rhythms 20200101

<h4>Purpose</h4>This review will trace the elements of neurostimulation for obstructive sleep apnea and details on its implementation, efficacy and safety, immediate clinical outcomes, and future prospects.<h4>Methods</h4>The literature on upper airway neurostimulation was surveyed from July, 2013, to July 2019, with a focus on the components of devices, evidence for clinical utility, and adverse events.<h4>Results</h4>Current technology is focused on the hypoglossal nerve stimulation (HNS). The ...[more]

PMID: 38031560

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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

Nerve Stimulation for the Treatment of Obstructive Sleep Apnea.

Purpose

Methods

Results

Conclusions

Publications

Nerve Stimulation for the Treatment of Obstructive Sleep Apnea.

Similar Datasets

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