Upper airway stimulation for obstructive sleep apnea : durability of the treatment effect at 18 months
Faculty of Medicine and Health Sciences
New York, N.Y.
Sleep. - New York, N.Y., 1978, currens
, p. 1593-1598
University of Antwerp
Objective: To determine the stability of improvement in polysomnographic measures of sleep disordered breathing, patient reported outcomes, the durability of hypoglossal nerve recruitment and safety at 18 months in the Stimulation Treatment for Apnea Reduction (STAR) trial participants. Design: Prospective multicenter single group trial with participants serving as their own controls. Setting: 22 community and academic sleep medicine and otolaryngology practices. Measurements: Primary outcome measures were the Apnea Hypopnea Index (AHI) and the 4% oxygen desaturation index (ODI). Secondary outcome measures were the Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), and oxygen saturation percent time <90% during sleep. Stimulation level for each participant was collected at three pre-defined thresholds during awake testing. Procedure and /or device related adverse events were reviewed and coded by the Clinical Events Committee Results: The median AHI was reduced by 67.4% from the baseline of 29.3 to 9.7 /hr at 18 months. The median ODI was reduced by 67.5% from 25.4 to 8.6 /hr at 18 months. The FOSQ and ESS improved significantly at 18 months compared to baseline values. The functional threshold was unchanged from baseline at 18 months. Two participants experienced a serious device-related adverse event requiring neurostimulator repositioning and fixation. No tongue weakness reported at 18 months Conclusion: Upper airway stimulation via the hypoglossal nerve maintained a durable effect of improving airway stability during sleep and improved patient reported outcomes (ESS and FOSQ) without an increase of the stimulation thresholds or tongue injury at 18 months of follow-up.