Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea : the STAR Trial
Faculty of Medicine and Health Sciences
Saint Louis, Ill.
Otolaryngology, head and neck surgery. - Saint Louis, Ill.
, p. 181-188
University of Antwerp
Objective: To describe the long term (36 month) clinical and polysomnographic outcomes in an OSA cohort treated with cranial nerve upper airway stimulation. Methods: 126 participants were enrolled in a prospective phase III trial evaluating the efficacy of Inspire II (Inspire Medical Systems, Minnesota, USA). Prospective outcomes included AHI, ODI, side effects and self-reported measures including sleepiness (ESS), sleep related quality of life (FOSQ), and snoring, .Data was collected at baseline and t select time points post-device activation. . Results: 116 of 126 enrolled patients completed 36 month follow up evaluation per protocol. 98 patients additionally agreed to an interval 36 month PSG. Daily device usage was 81%. In the interim PSG group, 74% met the a priori definition of success with the primary outcomes of AHI and ODI improved from baseline to 12 and 36 months (32.0±11.8 to 15.3±16.1 and 11.5±13.9 and 28.9±18.2 to 14.0±15.6 and 9.1±11.7, all p<0.01). Similarly, self- reported outcomes improved from baseline to 12 months and were maintained at 36 months. Soft or no snoring was reported in 86% at 36 months follow up. From 12 to 36 months, serious device related adverse events were rare with one device related explantion for ineffectiveness. Conclusion: Long term 3 year improvements in objective respiratory, self reported sleep, and sleep related quality of life measures are maintained. Adverse events are rare. Cranial nerve stimulation for the treatment of moderate to severe OSA is a successful and appropriate long term treatment of CPAP intolerant individuals with moderate to severe sleep apnea.