US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
NCT ID: NCT01211444
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
20 participants
INTERVENTIONAL
2010-07-31
2013-08-31
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 System
HGNS Treatment
The Apnex Hypoglossal Nerve Stimulation System (HGNS) 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 System (HGNS) 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 37.
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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Jon Freeman, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinilabs, Inc. West Side ENT, NY, NY
Tod Huntley, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Ear, Nose, Throat and Allegery, PC (Centa), Carmel, IN
Con Iber, MD
Role: PRINCIPAL_INVESTIGATOR
Dept of Neurology, University of Minnesota
Eric Kezirian, MD
Role: PRINCIPAL_INVESTIGATOR
University of Califoprnia - San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Saint Vincent Hospital
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Clinilabs, Inc.
New York, New York, United States
Countries
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Other Identifiers
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CLP-004
Identifier Type: -
Identifier Source: org_study_id
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