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Completed

NCT Number: NCT02501304

Feasibility Study of the ReVENT Sleep Apnea System

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReVENT Sleep Apnea System

Device

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

Primary outcomes

  1. Apnea-Hypopnea Index (AHI)

    Time frame: 24 months post-procedure

    Decrease in polysomnographically measured AHI post-intervention compared to baseline

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Sponsors and collaborators

Lead sponsor

Revent Medical International B.V.

Industry

Registry information

Official study title

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

Acronym: REV-001

Important dates

Study start
2011
Primary completion
2013
Study completion
2016
First posted
Jul 17, 2015
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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