Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six-month results.

Abstract

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.

• Authors: Michael Friedman, Ofer Jacobowitz, Michelle S Hwang, Wolfgang Bergler, Ingo Fietze, Philippe Rombaux, Gimbada B Mwenge, Sreeya Yalamanchali, John Campana, Joachim T Maurer
• Journal: The Laryngoscope (Laryngoscope) Vol. 126 Issue 11 Pg. 2618-2623 (11 2016) ISSN: 1531-4995 [Electronic] United States
• PMID: 27010361 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Topics

• Adult
• Aged
• Electric Stimulation Therapy (methods)
• Feasibility Studies
• Female
• Follow-Up Studies
• Humans
• Hypoglossal Nerve
• Implantable Neurostimulators
• Male
• Middle Aged
• Prospective Studies
• Prosthesis Implantation (methods)
• Severity of Illness Index
• Sleep Apnea, Obstructive (physiopathology, therapy)
• Treatment Outcome