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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
Sponsor:
Information provided by (Responsible Party):
Apnex Medical, Inc.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: HGNS Treatment Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline [ Time Frame: 6 months post-implant ]
  2. 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 :
  1. Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline [ Time Frame: 6 months post-implant ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Apnex Medical, Inc.
ClinicalTrials.gov Identifier: NCT01186926     History of Changes
Other Study ID Numbers: CLP-003
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: December 2011

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