NCT02501304

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

July 14, 2015

Last Update Submit

November 3, 2016

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea Index (AHI)

    Decrease in polysomnographically measured AHI post-intervention compared to baseline

    24 months post-procedure

Study Arms (1)

ReVENT Sleep Apnea System

EXPERIMENTAL

All patients will be implanted with the ReVENT Sleep Apnea System

Device: ReVENT Sleep Apnea System

Interventions

ReVENT Sleep Apnea SystemDEVICE

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

ReVENT Sleep Apnea System

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 17, 2015

Study Start

May 1, 2011

Primary Completion

August 1, 2013

Study Completion

April 1, 2016

Last Updated

November 4, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share