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Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
This study has been completed.
Sponsor:
Apnex Medical, Inc.
Information provided by (Responsible Party):
Apnex Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01186926
First received: August 20, 2010
Last updated: April 14, 2015
Last verified: December 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Obstructive Sleep Apnea | Device: HGNS Treatment | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Apnex Medical, Inc.:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline [ Time Frame: 6 months post-implant ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2009 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186926
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186926
Sponsors and Collaborators
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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Apnex Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01186926 History of Changes |
| Other Study ID Numbers: |
CLP-003 |
| Study First Received: | August 20, 2010 |
| Last Updated: | April 14, 2015 |
Keywords provided by Apnex Medical, Inc.:
|
Obstructive sleep apnea OSA hypoglossal nerve stimulation sleep apnea |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 23, 2017