Details

Autor(en) / Beteiligte

• Woodson, B. Tucker
• Soose, Ryan J.
• Gillespie, M. Boyd
• 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.

Titel

Three-Year Outcomes of Cranial Nerve Stimulation for Obstructive Sleep Apnea: The STAR Trial

Ist Teil von

• Otolaryngology-head and neck surgery, 2016-01, Vol.154 (1), p.181-188

Ort / Verlag

Los Angeles, CA: SAGE Publications

Erscheinungsjahr

2016

Link zum Volltext

Quelle

Wiley Online Library All Journals

Beschreibungen/Notizen

• Objective To describe the 36-month clinical and polysomnography (PSG) outcomes in an obstructive sleep apnea (OSA) cohort treated with hypoglossal cranial nerve upper airway stimulation (UAS). Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical setting. Subjects Participants (n = 116) at 36 months from a cohort of 126 implanted participants. Methods Participants were enrolled in a prospective phase III trial evaluating the efficacy of UAS for moderated to severe OSA. Prospective outcomes included apnea-hypopnea index, oxygen desaturation index, other PSG measures, self-reported measures of sleepiness, sleep-related quality of life, and snoring. Results Of 126 enrolled participants, 116 (92%) completed 36-month follow-up evaluation per protocol; 98 participants additionally agreed to a voluntary 36-month PSG. Self-report daily device usage was 81%. In the PSG group, 74% met the a priori definition of success with the primary outcomes of apnea-hypopnea index, reduced from the median value of 28.2 events per hour at baseline to 8.7 and 6.2 at 12 and 36 months, respectively. Similarly, self-reported outcomes improved from baseline to 12 months and were maintained at 36 months. Soft or no snoring reported by bed partner increased from 17% at baseline to 80% at 36 months. Serious device-related adverse events were rare, with 1 elective device explantation from 12 to 36 months. Conclusion Long-term 3-year improvements in objective respiratory and subjective quality-of-life outcome measures are maintained. Adverse events are uncommon. UAS is a successful and appropriate long-term treatment for individuals with moderate to severe OSA.