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

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 coho...

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Bibliographic Details
Published in:Otolaryngology-head and neck surgery 2017-04, Vol.156 (4), p.765-771
Main Authors: 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.
Format: Article
Language:English
Subjects:
apnea hypopnea index
clinical
cranial nerve
device
Disorders of Excessive Somnolence - therapy
Electric Stimulation Therapy
Follow-Up Studies
Humans
Hypoglossal Nerve
implant
Implantable Neurostimulators
long term
Male
Middle Aged
obstructive sleep apnea
Patient Reported Outcome Measures
Prospective Studies
Quality of Life
Self Report
sleep
Sleep Apnea, Obstructive - therapy
Snoring - therapy
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Summary: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.
ISSN:0194-5998
1097-6817
DOI:10.1177/0194599817691491