REV 002 Observational Study of the ReVENT Sleep Apnea System: Minimally Invasive Treatment for Obstructive Sleep Apnea

Terminated

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: ReVENT Sleep Apnea System

• Registration Number: NCT02180815
• Lead Sponsor: Revent Medical International B.V.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Study Start: 2014-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patient diagnosed with Obstructive Sleep Apnea due to primary tongue base closure.
• AHI ≥ 10 and AHI ≤ 40 (at least 90% of apneas and hypopneas must be obstructive).
• BMI ≤ 32.
• Confirmation of tongue base closure as the primary source of obstruction with Drug Induced Sleep Endoscopy (DISE).

Exclusion Criteria

• Patient with prior tongue-base surgery
• Uvulopalatopharyngoplasty, soft palate surgery, tonsillectomy or minimally invasive RF ablation of the tongue within the last six (6) months.
• History of mandibular and/or hyoid advancement to treat OSA.
• Any contraindications as listed in the approved Instructions for Use.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ReVENT implanted group	ReVENT Sleep Apnea System	-

Primary Outcome Measures

Name	Time	Method
Reduction in Apnea-Hypopnea Index (AHI)	3, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Patient perception of benefit as measured by change in daytime sleepiness and sleep-related quality of life	3, 6 and 12 months

Trial Locations

Locations (14)

Alfried Krupp Krankenhaus; 🇩🇪 Essen, Germany

Universitäts-HNO-Klinik Mannheim; 🇩🇪 Mannheim, Germany

Cliniques Universitaires Saint Luc; 🇧🇪 Bruxelles, Belgium

University Hospital Antwerp; 🇧🇪 Edegem, Belgium

ISALA Afdeling KNO-Heelkunde Isala; 🇳🇱 Zwolle, Netherlands

St Joseph-Stift; 🇩🇪 Bremen, Germany

Universitätsklinikum HNO-Klinik; 🇩🇪 Ulm, Germany

Pavelec LENTE, Ltd.; 🇨🇿 Plzeň, Czech Republic

Sint Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Asklepios Klinik Harburg; 🇩🇪 Hamburg, Germany

Cantonal Hospital Baselland - ENT Department; 🇨🇭 Liestal, Switzerland

MC Slotervaart; 🇳🇱 Amsterdam, Netherlands

Klinikum Ernst von Bergmann; 🇩🇪 Potsdam, Germany

St. Franziskus Hospital HNO-Klinik; 🇩🇪 Köln, Germany