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Clinical Trial
. 2016 Nov;126(11):2618-2623.
doi: 10.1002/lary.25909. Epub 2016 Mar 24.

Targeted Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea: Six-month Results

Clinical Trial

Targeted Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea: Six-month Results

Michael Friedman et al. Laryngoscope. .


Objectives/hypothesis: This feasibility study was designed to show the preliminary safety and efficacy of targeted hypoglossal neurostimulation (THN), and to identify baseline predictors of successful therapy.

Study design: Open-label, prospective, multicenter, single-arm cohort study, conducted at seven centers in the U.S.A. and Europe.

Methods: Forty-six participants with moderate to severe obstructive sleep apnea (OSA), failing or intolerant of continuous positive airway pressure, were implanted. Primary (Apnea-Hypopnea Index [AHI], Oxygen Desaturation Index [ODI]) and secondary (Arousal Index, Epworth Sleepiness Scale Index, Sleep Apnea Quality of Life Index) outcomes were measured at baseline and compared at 6 months. Data were analyzed to identify participant characteristics that would predict success with therapy.

Results: Sixty-seven adverse events (AEs) were observed among 36 participants; most of the AEs were related to the implant procedure and resolved without sequelae; one device replacement was necessary. Forty-three participants showed significant (P < .01) decreases in both AHI and ODI at 6 months; 35% (15 of 43) met criteria for AHI responders and 40% (17 of 43) for ODI responders. Significant improvement was observed in all the secondary endpoints. Predictors-of-success selection criteria were identified as baseline AHI < 65/hr, baseline apnea index ≤ 30, baseline body mass index < 35, and <15 events/hr of SpO2 decrease > 10%. Seven participants met these criteria; 86% (6 of 7) were AHI responders and 86% (6 of 7) were ODI responders, indicating that THN therapy can be efficacious in a carefully selected population of OSA patients.

Conclusions: This feasibility study suggests that THN therapy is likely to be safe and effective in selected patients.

Level of evidence: 2b Laryngoscope, 126:2618-2623, 2016.

Keywords: Hypoglossal nerve stimulation; hypoglossal nerve; neurostimulation; obstructive sleep apnea; surgical treatment of obstructive sleep apnea.

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