Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post‐market study

OBJECTIVE/HYPOTHESIS: Upper airway stimulation (UAS) of the hypoglossal nerve has been implemented in the routine clinical practice for patients with moderate-to-severe obstructive sleep apnea (OSA) who could not adhere to continuous positive airway pressure. This study reports objective and patient-reported outcome after 12 months of implantation. STUDY DESIGN: Multicenter prospective single-arm study. METHODS: , apnea-hypopnea index (AHI) 65, or complete concentric collapse at the soft palate during sedated endoscopy. Data collection at 6- and 12-month visit include home sleep test and patient-reported outcome measures. RESULTS: Among the total of 60 participants, the median AHI reduced from 28.6 to 9.5 from baseline to 12 months. Patient-reported outcome measured in Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire both improved significantly from baseline to 12 months. The average usage time was 39.1 ± 14.9 hours per week among all participants based on recordings by the implanted device. One patient requested a removal of the device for cosmetic and other personal reasons and was completed without sequelae. CONCLUSION: This study supported that UAS is a safe and effective treatment option for patients with OSA in routine clinical practice. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:509-515, 2018.