In:
The Laryngoscope, Wiley, Vol. 126, No. 11 ( 2016-11), p. 2618-2623
Abstract:
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 SpO 2 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
Type of Medium:
Online Resource
ISSN:
0023-852X
,
1531-4995
DOI:
10.1002/lary.v126.11
Language:
English
Publisher:
Wiley
Publication Date:
2016
detail.hit.zdb_id:
2026089-1
