Abstract
Objective: OSA is a common cause of sleep morbidity. A novel treatment for obstruction at the level of the tongue is a unilateral hypoglossal nerve implant system (Inspire, Inspire Medical, Minneapolis, Minnesota). Study objectives were to assess sleep outcomes in a multicenter academic setting feasibility trial.
Method: Nerve stimulation effect on AHI and self reported sleep outcomes were assessed at two and six months (Epworth Sleepiness Score (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ).
Results: Thirty-one subjects underwent placement of a unilateral hypoglossal nerve implant (two explanted). Fifty-five percent of subjects at 6 months were AHI responders (AHI < 20/hr. and 50% reduction). In the entire group, ESS improved (baseline=10.7(4.9) 2 months= 8.2(4.0), 6 months= 7.7(4.2), P < .005). At baseline, 2 months and 6 months: ESS improved in both responders (10.4 to 8.0 to 6.6) and non-responders (11.8 to 9.4 to 8.9), and FOSQ improved and normalized in responders (15.6 to 17.1 to 18.0, P < .05) but not non-responders (13.6 to 14.2 to 15.2, P = NS).
Conclusion: Sleep outcomes improved using a hypoglossal nerve implant. Consistent with other interventions, ESS improvements were unrelated to change in AHI. FOSQ improvements were observed in responders but not non-responders. Data support a clinical device effect but highlight the need for controlled studies to evaluate sleep outcomes in surgical trials.
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