Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea

April 14, 2015 updated by: Apnex Medical, Inc.

Australian Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

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

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Eligibility Criteria

  1. Previously diagnosed with moderate to severe obstructive sleep apnea.
  2. Subject has failed or does not tolerate CPAP treatment.
  3. Age between 21 and 70 years.
  4. Body mass index (BMI) less than or equal to 40

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: HGNS Treatment
Device: HGNS Treatment
The Apnex Hypoglossal Nerve Stimulation (HGNS) System is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping, and off when the patient is awake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Time Frame: 6 months post-implant
6 months post-implant
Adverse event profile interoperatively, perioperatively, and long term post implant
Time Frame: 1, 3, 6, 12, 24, and 36 months post implant
1, 3, 6, 12, 24, and 36 months post implant

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline
Time Frame: 6 months post-implant
6 months post-implant

Collaborators and Investigators

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

Sponsor

Apnex Medical, Inc.

Investigators

  • Principal Investigator: Maree Barnes, MD, Institute for Breathing and Sleep, Austin Health
  • Principal Investigator: David Hillman, MD, West Australian Sleep Disorders Research Institute, St. Charles Gardner Hospital
  • Principal Investigator: Doug McEvoy, MD, Adelaide Institute for Sleep Health, Repatriation General Hospital
  • Principal Investigator: John Wheatley, MD, Westmead Hospital Dept of Respiratory Medicine

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

March 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-003

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.

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