Targeted Hypoglossal Neurostimulation Study #3

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT02263859

Run by

ImThera Medical, Inc.

People needed

138

Starts

2015-02-01

Expected to finish

2023-09-01

Last updated by the study team

2024-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Exclusion Critera:
• Implanted with another active implantable device
• Body mass index (BMI) ≥ 35 kg/m²

Where it is running

• ENT Associates of San Diego — Chula Vista, California, United States
• Tower ENT — Los Angeles, California, United States
• SENTA Clinic — San Diego, California, United States
• Ear, Nose, and Throat Associates of South Florida — Boca Raton, Florida, United States
• Morton Plant Mease Healthcare — Safety Harbor, Florida, United States
• Advanced ENT Asociates — Atlanta, Georgia, United States
• Center for ENT and Allergy — Carmel, Indiana, United States
• Kentucky Research Group — Louisville, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• ENT and Allergy Associates — New York, New York, United States
• Intrepid Research — Cincinnati, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UT Methodist Physicians — Memphis, Tennessee, United States
• FutureSearch Trials — Austin, Texas, United States
• Clinique Univ. Saint-Luc — Brussels, Belgium
• Pitie Salpetriere — Paris, France
• Foch Hospital — Suresnes, France
• Ruprechts-Karls University — Mannheim, Germany
• Bnai Zion Medical Center — Haifa, Israel
• Hospital CUF Porto — Porto, Portugal

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.