The purpose of this post-market observational study is to assess the effectiveness and patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with Obstructive Sleep Apnea due to primary tongue base closure. The ReVENT Sleep Apnea System is a minimally invasive surgical approach to treat Obstructive Sleep Apnea. The ReVENT Sleep Apnea System consists of an implanter kit and tongue implants. The implants are permanently implanted in the tongue during a minimally invasive outpatient surgical procedure to prevent tongue base closure during sleep.
Study Type
OBSERVATIONAL
Enrollment
50
Cliniques Universitaires Saint Luc
Brussels, Belgium
University Hospital Antwerp
Edegem, Belgium
Pavelec LENTE, Ltd.
Pilsen, Czechia
St Joseph-Stift
Bremen, Germany
St. Franziskus Hospital HNO-Klinik
Cologne, Germany
Alfried Krupp Krankenhaus
Essen, Germany
Asklepios Klinik Harburg
Hamburg, Germany
Universitäts-HNO-Klinik Mannheim
Mannheim, Germany
Klinikum Ernst von Bergmann
Potsdam, Germany
Universitätsklinikum HNO-Klinik
Ulm, Germany
...and 4 more locations
Reduction in Apnea-Hypopnea Index (AHI)
Time frame: 3, 6 and 12 months
Patient perception of benefit as measured by change in daytime sleepiness and sleep-related quality of life
Time frame: 3, 6 and 12 months
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