Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
NCT ID: NCT01186926
Last Updated: 2015-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2009-03-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HGNS Treatment
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.
Interventions
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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 Criteria
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Inclusion 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
21 Years
70 Years
ALL
No
Sponsors
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Apnex Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Maree Barnes, MD
Role: PRINCIPAL_INVESTIGATOR
Institute for Breathing and Sleep, Austin Health
David Hillman, MD
Role: PRINCIPAL_INVESTIGATOR
West Australian Sleep Disorders Research Institute, St. Charles Gardner Hospital
Doug McEvoy, MD
Role: PRINCIPAL_INVESTIGATOR
Adelaide Institute for Sleep Health, Repatriation General Hospital
John Wheatley, MD
Role: PRINCIPAL_INVESTIGATOR
Westmead Hospital Dept of Respiratory Medicine
References
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Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep. 2011 Nov 1;34(11):1479-86. doi: 10.5665/sleep.1380.
Other Identifiers
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CLP-003
Identifier Type: -
Identifier Source: org_study_id
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