Three Year Outcomes of Cranial Nerve Stimulation for Obstructive Sleep Apnea
Objective To describe the 36 month clinical and polysomnography (PSG) outcomes in an obstructive sleep apnea (OSA) cohort treated with hypoglossal cranial nerve upper airway stimulation (UAS) Study Design A multicenter prospective cohort study. Setting Industry supported multicenter academic and clinical setting. Subjects Participants (n 116) at 36 months from a cohort of 126 implanted participants. Methods Participants were enrolled in a prospective phase III trial evaluating the efficacy of UAS for moderated to severe OSA. Prospective outcomes included apnea hypopnea index, oxygen desaturation index, other PSG measures, self reported measures of sleepiness, sleep related quality of life, and snoring. Results Of 126 enrolled participants, 116 (92% completed 36 month follow up evaluation per protocol; 98 participants additionally agreed to a voluntary 36 month PSG. Self report daily device usage was 81% In the PSG group, 74% met the a priori definition of success with the primary outcomes of apnea hypopnea index, reduced from the median value of 28.2 events per hour at baseline to 8.7 and 6.2 at 12 and 36 months, respectively. Similarly, self reported outcomes improved from baseline to 12 months and were maintained at 36 months. Soft or no snoring reported by bed partner increased from 17% at baseline to 80% at 36 months. Serious device related adverse events were rare, with 1 elective device explantation from 12 to 36 months. Conclusion Long term 3 year improvements in objective respiratory and subjective quality of life outcome measures are maintained. Adverse events are uncommon. UAS is a successful and appropriate long term treatment for individuals with moderate to severe OSA.
Otolaryngology head and neck surgery official journal of American Academy of Otolaryngology Head and Neck Surgery