Faculty Collaboration Database

Three-Year Outcomes of Cranial Nerve Stimulation for Obstructive Sleep Apnea: The STAR Trial. Otolaryngol Head Neck Surg 2016 Jan;154(1):181-8

Date

11/19/2015

Pubmed ID

26577774

DOI

10.1177/0194599815616618

Scopus ID

2-s2.0-84954153194 (requires institutional sign-in at Scopus site)   187 Citations

Abstract

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.

Author List

Woodson BT, Soose RJ, Gillespie MB, Strohl KP, Maurer JT, de Vries N, Steward DL, Baskin JZ, Badr MS, Lin HS, Padhya TA, Mickelson S, Anderson WM, Vanderveken OM, Strollo PJ Jr, STAR Trial Investigators

Author

B Tucker Woodson MD Chief, Professor in the Otolaryngology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Cohort Studies
Cranial Nerves
Electric Stimulation Therapy
Female
Humans
Implantable Neurostimulators
Male
Middle Aged
Prospective Studies
Sleep Apnea, Obstructive
Time Factors
Treatment Outcome