Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
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ClinicalTrials.gov Identifier: NCT01186926 |
Recruitment Status :
Completed
First Posted : August 23, 2010
Last Update Posted : April 15, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea | Device: HGNS Treatment | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Australian Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | May 2013 |

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. |
- Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline [ Time Frame: 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 ]
- Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline [ Time Frame: 6 months post-implant ]

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Ages Eligible for Study: | 21 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Eligibility Criteria
- Previously diagnosed with moderate to severe obstructive sleep apnea.
- Subject has failed or does not tolerate CPAP treatment.
- Age between 21 and 70 years.
- Body mass index (BMI) less than or equal to 40

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186926
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 |
Responsible Party: | Apnex Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT01186926 |
Other Study ID Numbers: |
CLP-003 |
First Posted: | August 23, 2010 Key Record Dates |
Last Update Posted: | April 15, 2015 |
Last Verified: | December 2011 |
Obstructive sleep apnea OSA hypoglossal nerve stimulation sleep apnea |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |