Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
NCT ID: NCT04950894
Last Updated: 2025-05-01
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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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2021-07-27
2025-10-30
Brief Summary
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Detailed Description
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The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13)
Safety and efficacy will be evaluated at Month 7, and again at Month 13.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Active
HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13
Hypoglossal Nerve Stimulation
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
Control
HGN therapy NOT activated at Month 1 - compared at Month 7 to Active group, stimulation will start at Month 7 + 1 Day and continue through Month 13
Hypoglossal Nerve Stimulation
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
Interventions
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Hypoglossal Nerve Stimulation
Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
Eligibility Criteria
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Inclusion Criteria
* Declines to use or does not tolerate PAP therapy
Exclusion Criteria
* BMI \> 35 kg/m2
* Specific PSG criteria outlined in the protocol
22 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Principal Investigators
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Atul Malhotra, MD
Role: PRINCIPAL_INVESTIGATOR
UCSD Pulmonary and Critical Care Medicine
Locations
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University of Alabama At Birmingham
Birmingham, Alabama, United States
Banner Health
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Sacramento Ent
Roseville, California, United States
Paul Schalch Lepe, Md/Silenso Clinic
San Diego, California, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, United States
Morton Plant Mease Health Care
Safety Harbor, Florida, United States
Advanced Ent Associates
Atlanta, Georgia, United States
Norton Healthcare
Louisville, Kentucky, United States
Alivation Research Llc
Lincoln, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Raleigh Neurology Associates, Pa
Raleigh, North Carolina, United States
Penn State Health
Hershey, Pennsylvania, United States
Philadelphia Ear, Nose and Throat Associates
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Bogan Sleep Consultants, Llc
Columbia, South Carolina, United States
Houston Methodist
Houston, Texas, United States
Epic Medical Research
Red Oak, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Jacobowitz O, Schwartz AR, Lovett EG, Ranuzzi G, Malhotra A. Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial. Contemp Clin Trials. 2022 Aug;119:106804. doi: 10.1016/j.cct.2022.106804. Epub 2022 May 22.
Other Identifiers
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LNS005
Identifier Type: -
Identifier Source: org_study_id
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