Upper Airway Stimulation for Obstructive Sleep Apnea: Patient-Reported Outcomes after 48 Months of Follow-up

作者：Gillespie M Boyd^*; Soose Ryan J; Woodson B Tucker; Strohl Kingman P; Maurer Joachim T; de Vries Nico; Steward David L; Baskin Jonathan Z; Badr M Safwan; Lin Ho sheng; Padhya Tapan A; Mickelson Sam; Anderson W McDowell; Vanderveken Olivier M; Strollo Patrick J Jr

来源：Otolaryngology - Head and Neck Surgery, 2017, 156(4): 765-771.

DOI：10.1177/0194599817691491

• obstructive sleep apnea
• cranial nerve
• hypoglossal nerve
• sleep
• device
• implant
• long term
• clinical
• apnea hypopnea index
• sleep
• quality of life

Objective. To assess patient-based outcomes of participants in a large cohort study-the STAR trial (Stimulation Therapy for Apnea Reduction)-48 months after implantation with an upper airway stimulation system for moderate to severe obstructive sleep apnea.
Study Design. A multicenter prospective cohort study.
Setting. Industry-supported multicenter academic and clinical setting.
Subjects. Participants (n = 91) at 48 months from a cohort of 126 implanted participants.
Methods. A total of 126 participants received an implanted upper airway stimulation system in a prospective phase III trial. Patient-reported outcomes at 48 months, including Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and snoring level, were compared with preimplantation baseline.
Results. A total of 91 subjects completed the 48-month visit. Daytime sleepiness as measured by ESS was significantly reduced (P = .01), and sleep-related quality of life as measured by FOSQ significantly improved (P = .01) when compared with baseline. Soft to no snoring was reported by 85% of bed partners. Two patients required additional surgery without complication for lead malfunction.
Conclusion. Upper airway stimulation maintained a sustained benefit on patient-reported outcomes (ESS, FOSQ, snoring) at 48 months in select patients with moderate to severe obstructive sleep apnea.

• 出版日期2017-4