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Otolaryngol Head Neck Surg. 2016 Jan;154(1):181-8. doi: 10.1177/0194599815616618. Epub 2015 Nov 17.

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

Author information

1
Medical College of Wisconsin, Milwaukee, Wisconsin, USA bwoodson@mcw.edu.
2
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
3
Medical University of South Carolina, Charleston, South Carolina, USA.
4
Case Western Reserve University, Cleveland, Ohio, USA.
5
University Hospital Mannheim, Mannheim, Germany.
6
Saint Lucas Andreas Hospital, Amsterdam, Netherlands.
7
University of Cincinnati Medical Center, Cincinnati, Ohio, USA.
8
Wayne State University, Detroit, Michigan, USA.
9
University of South Florida College of Medicine, Tampa, Florida, USA.
10
Advanced ENT, Atlanta, Georgia, USA.
11
Antwerp University Hospital, Edegem, Belgium.

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.

KEYWORDS:

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

PMID:
26577774
DOI:
10.1177/0194599815616618
[Indexed for MEDLINE]

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