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Feasibility Study of the ReVENT Sleep Apnea System (REV-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501304
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Revent Medical International B.V.

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea (OSA) Device: ReVENT Sleep Apnea System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the ReVENT Sleep Apnea System for the Treatment of Obstructive Sleep Apnea (OSA)
Study Start Date : May 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: ReVENT Sleep Apnea System
All patients will be implanted with the ReVENT Sleep Apnea System
Device: ReVENT 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




Primary Outcome Measures :
  1. Apnea-Hypopnea Index (AHI) [ Time Frame: 24 months post-procedure ]
    Decrease in polysomnographically measured AHI post-intervention compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Revent Medical International B.V.
ClinicalTrials.gov Identifier: NCT02501304    
Other Study ID Numbers: REV-001
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases