ImThera Medical Targeted Hypoglossal Neurostimulation Study #3
Status: Completed
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \>18 years
• Individual has failed or does not tolerate PAP therapy
• Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and behavioral treatments)
• AHI ≥ 20 (Moderate to severe OSA)
Locations
United States
California
ENT Associates of San Diego
Chula Vista
Tower ENT
Los Angeles
SENTA Clinic
San Diego
Florida
Ear, Nose, and Throat Associates of South Florida
Boca Raton
Morton Plant Mease Healthcare
Safety Harbor
Georgia
Advanced ENT Asociates
Atlanta
Indiana
Center for ENT and Allergy
Carmel
Kentucky
Kentucky Research Group
Louisville
Maryland
Johns Hopkins University
Baltimore
New York
ENT and Allergy Associates
New York
Ohio
Intrepid Research
Cincinnati
South Carolina
Medical University of South Carolina
Charleston
Tennessee
UT Methodist Physicians
Memphis
Texas
FutureSearch Trials
Austin
Other Locations
Belgium
Clinique Univ. Saint-Luc
Brussels
France
Pitie Salpetriere
Paris
Foch Hospital
Suresnes
Germany
Ruprechts-Karls University
Mannheim
Israel
Bnai Zion Medical Center
Haifa
Portugal
Hospital CUF Porto
Porto
Time Frame
Start Date: 2015-02
Completion Date: 2023-09-01
Participants
Target number of participants: 138
Treatments
Experimental: Treatment
The Treatment Group will be implanted with the aura6000 System and have therapy turned ON at the Month 1 follow-up visit.
Other: Control
The Control Group will be implanted with the aura6000 System and receive treatment as-usual, (i.e. any non-PAP, non-surgical OSA treatment including oral appliances and positional devices being used prior to enrollment in the study) until 14 days (washout period) prior to the Month 4 visit. At the Month 4 + 1 day follow-up visit, subjects in the Control Group will have therapy turned ON for the duration of the study.
Authors
Nathan Nachlas, Paul Schalch, Marion B Gillespie, Ofer Jacobowitz, Joseph Hellmann, David Eisele, John D. Hudson, Brian Weeks, David Alessi, Tod Huntley, Joseph Hellman, Shaun Nguyen, Lee Mandel, Bruce Corser, Samuel A Mickelson, Mitchell Miller, Alan R Schwartz, Robert Nason, James Barna, Valerie Attali, Frédéric Chabolle, Chloe Bertolus, Robert Ruder, Martin L Hopp, Victor Certal, Arie Oliven, Philippe Rombaux
Related Therapeutic Areas
Sponsors
Leads: ImThera Medical, Inc.
Collaborators: LivaNova