Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea in a Multicenter German Postmarket Study

Clemens Heiser*, Joachim T. Maurer, Benedikt Hofauer, J. Ulrich Sommer, Annemarie Seitz, Armin Steffen

*Korrespondierende/r Autor/-in für diese Arbeit
37 Zitate (Scopus)

Abstract

Objective Selective stimulation of the hypoglossal nerve is a new surgical therapy for obstructive sleep apnea, with proven efficacy in well-designed clinical trials. The aim of the study is to obtain additional safety and efficacy data on the use of selective upper airway stimulation during daily clinical routine. Study Design Prospective single-arm study. Setting Three tertiary hospitals in Germany (Munich, Mannheim, Lübeck). Subjects and Methods A multicenter prospective single-arm study under a common implant and follow-up protocol took place in 3 German centers (Mannheim, Munich, Lübeck). Every patient who received an implant of selective upper airway stimulation was included in this trial (apnea-hypopnea index ≥15/h and ≤65/h and body mass index <35 kg/m2). Before and 6 months after surgery, a 2-night home sleep test was performed. Data regarding the safety and efficacy were collected. Results From July 2014 through October 2015, 60 patients were included. Every subject reported improvement in sleep and daytime symptoms. The average usage time of the system was 42.9 ± 11.9 h/wk. The median apnea-hypopnea index was significantly reduced at 6 months from 28.6/h to 8.3/h. No patient required surgical revision of the implanted system. Conclusion Selective upper airway stimulation is a safe and effective therapy for patients with obstructive sleep apnea and represents a powerful option for its surgical treatment.

OriginalspracheEnglisch
ZeitschriftOtolaryngology - Head and Neck Surgery (United States)
Jahrgang156
Ausgabenummer2
Seiten (von - bis)378-384
Seitenumfang7
ISSN0194-5998
DOIs
PublikationsstatusVeröffentlicht - 01.02.2017

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  • Profilbereich: Lübeck Integrated Oncology Network (LION)

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