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Sleep. 2015 Oct 1;38(10):1593-8. doi: 10.5665/sleep.5054.

Upper Airway Stimulation for Obstructive Sleep Apnea: Durability of the Treatment Effect at 18 Months.

Author information

1
Division of Pulmonary Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.
2
Department of Otolaryngology, Medical College of South Carolina Charleston, SC.
3
Department of Otolaryngology, University of Pittsburgh, Pittsburgh, PA.
4
Department of Otorhinolaryngology, Head & Neck Surgery, Sleep Disorders Center, University Hospital Mannheim, Mannheim, Germany.
5
Department of Otolaryngology,Saint Lucas Hospital, Amsterdam, Netherlands.
6
North Memorial Sleep Health Center, Maple Grove, MN.
7
St. Cloud Ear, Nose & Throat, St. Cloud, MN.
8
Department of Otolaryngology - Head and Neck Surgery, University of South Florida College of Medicine, Tampa, FL.
9
Department of Otolaryngology - Head and Neck Surgery, University of Cincinnati Academic Health Center, Cincinnati, OH.
10
Department of Otolaryngology and Human Communication, Medical College of Wisconsin, Milwaukee, WI.
11
Department of Pulmonary Medicine, Multidisciplinary Sleep Disorders Center, Antwerp University Hospital, Antwerp, Belgium.
12
Department of Otorhinolaryngology and Head & Neck Surgery, Multidisciplinary Sleep Disorders Center, Antwerp University Hospital, Antwerp, Belgium.
13
Sleep Disorders Center, Borgess Medical Center, Kalamazoo, MI.
14
St. Petersburg Sleep Disorders Center St. Petersburg, FL.
15
Hôpital Foch, Suresnes, France.
16
Division of Pulmonary, Critical Care & Sleep Medicine, Wayne State University, Detroit, MI.
17
Krankenhaus Bethanien Solingen, Soligen, Germany.
18
Division of Pulmonary, Critical Care & Sleep Medicine, Case Western Reserve University, Cleveland, OH.

Abstract

OBJECTIVE:

To determine the stability of improvement in polysomnographic measures of sleep disordered breathing, patient reported outcomes, the durability of hypoglossal nerve recruitment and safety at 18 months in the Stimulation Treatment for Apnea Reduction (STAR) trial participants.

DESIGN:

Prospective multicenter single group trial with participants serving as their own controls.

SETTING:

Twenty-two community and academic sleep medicine and otolaryngology practices.

MEASUREMENTS:

Primary outcome measures were the apnea-hypopnea index (AHI) and the 4% oxygen desaturation index (ODI). Secondary outcome measures were the Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), and oxygen saturation percent time < 90% during sleep. Stimulation level for each participant was collected at three predefined thresholds during awake testing. Procedure- and/or device-related adverse events were reviewed and coded by the Clinical Events Committee.

RESULTS:

The median AHI was reduced by 67.4% from the baseline of 29.3 to 9.7/h at 18 mo. The median ODI was reduced by 67.5% from 25.4 to 8.6/h at 18 mo. The FOSQ and ESS improved significantly at 18 mo compared to baseline values. The functional threshold was unchanged from baseline at 18 mo. Two participants experienced a serious device-related adverse event requiring neurostimulator repositioning and fixation. No tongue weakness reported at 18 mo.

CONCLUSION:

Upper airway stimulation via the hypoglossal nerve maintained a durable effect of improving airway stability during sleep and improved patient reported outcomes (Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire) without an increase of the stimulation thresholds or tongue injury at 18 mo of follow-up.

KEYWORDS:

hypoglossal nerve stimulation; obstructive sleep apnea; pacing; therapy; upper airway stimulation

PMID:
26158895
PMCID:
PMC4576333
DOI:
10.5665/sleep.5054
[Indexed for MEDLINE]
Free PMC Article

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