Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

August 8, 2019 updated by: ImThera Medical, Inc.

A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea

The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Clinique Univ. Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to severe obstructive sleep apnea (AHI 15 to 60).
  • Cannot or will not tolerate CPAP treatment.
  • Body mass index (BMI) between 25 and 40
  • Able to read, understand, sign and date the written informed consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: THN Therapy
Device: aura6000 System
The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline.
Time Frame: 3 and 12 months post-implant
3 and 12 months post-implant
Adverse events and Serious Adverse events peri and post-operatively
Time Frame: 3 and 12 months post-operative
3 and 12 months post-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline.
Time Frame: 3 and 12 months post-operative
3 and 12 months post-operative
Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline.
Time Frame: 3 and 12 months post-implantation
3 and 12 months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImThera Medical, Inc.

Investigators

  • Principal Investigator: Daniel Rodenstein, MD, Clinique Univ. Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 14, 2012

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMT 2009-01/02/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Apnea Syndromes

Clinical Trials on aura6000 System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe