Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
NCT ID: NCT01446601
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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TERMINATED
PHASE3
132 participants
INTERVENTIONAL
2011-08-31
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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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment
The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant.
Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.
Control
The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.
Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.
Interventions
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Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≤ 35 kg/m²
* Previously diagnosed with Moderate to severe OSA
* Individual has failed or does not tolerate PAP therapy
21 Years
80 Years
ALL
No
Sponsors
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Apnex Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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MidAmerica Neuroscience Research Institute
Lenexa, Kansas, United States
Veritas Clinical Specialties
Topeka, Kansas, United States
Kentucky Research Group
Louisville, Kentucky, United States
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
St. Lukes Hospital
St Louis, Missouri, United States
Clinilabs
New York, New York, United States
Wilmington Medical Research
Wilmington, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Sleep Med of South Carolina
Columbia, South Carolina, United States
Sleep Therapy and Research Center
San Antonio, Texas, United States
Westmead Hospital
Sydney, New South Wales, Australia
IBAS, The Austin Hospital
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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IDE #G090014
Identifier Type: OTHER
Identifier Source: secondary_id
CLP-005
Identifier Type: -
Identifier Source: org_study_id
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