Feasibility Study of the ReVENT Sleep Apnea System

Feasibility Study of the ReVENT Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02501304

Acronym

REV-001

Enrollment

Registered

2015-07-17

Start date

2011-05-31

Completion date

2016-04-30

Last updated

2016-11-04

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

Conditions

Obstructive Sleep Apnea (OSA)

Brief summary

This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.

Interventions

DEVICEReVENT Sleep Apnea System

The ReVENT Sleep Apnea System consists of minimally invasive biocompatible devices that are placed into the tongue base and palate of patients with obstructive sleep apnea

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of OSA with AHI 15-40 * Body Mass Index (BMI) ≤ 32 * Refused or failed Continuous Positive Airway Pressure (CPAP) * Evidence of airway collapse at soft palate and/or base of tongue

Exclusion criteria

* Prior OSA surgery * Anatomy unable to accommodate implants * Chronic immunosuppressive therapy or known problems with wound healing * Type I or II diabetes * Active systemic infection * Pregnancy * Other major medical conditions that could confound outcome measures or interfere with study completion

Design outcomes

Primary

Measure	Time frame	Description
Apnea-Hypopnea Index (AHI)	24 months post-procedure	Decrease in polysomnographically measured AHI post-intervention compared to baseline

Outcome results

None listed

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