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

ReVENT Sleep Apnea System, a Minimally Invasive Approach to Treat Obstructive Sleep Apnea: a Prospective Multicenter Post-Market Observational Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02180815

Enrollment

Registered

2014-07-03

Start date

2014-09-30

Completion date

2017-04-30

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Obstructive Sleep Apnea due to primary tongue base closure, Minimally invasive surgery, ReVENT Sleep Apnea System, Tongue implants

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.

Interventions

DEVICEReVENT Sleep Apnea System

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame
Safety profile assessed by incidence of adverse events	1 week, 6 and 12 months

Countries

Belgium, Czechia, Germany, Netherlands, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026