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

NCT01186926 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-04-15

No results posted yet for this study

Summary

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Apnex Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Maree Barnes, MD · Institute for Breathing and Sleep, Austin Health

  • David Hillman, MD · West Australian Sleep Disorders Research Institute, St. Charles Gardner Hospital

  • Doug McEvoy, MD · Adelaide Institute for Sleep Health, Repatriation General Hospital

  • John Wheatley, MD · Westmead Hospital Dept of Respiratory Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-12-31
Completion
2013-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01186926 on ClinicalTrials.gov