Status:
COMPLETED
Targeted Hypoglossal Neurostimulation Study #3
Lead Sponsor:
ImThera Medical, Inc.
Collaborating Sponsors:
LivaNova
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 moderat...
Detailed Description
The objectives of this study are to evaluate the safety and effectiveness of the aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals who have failed or...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT02263859
Start Date
February 1 2015
End Date
September 1 2023
Last Update
February 7 2024
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
ENT Associates of San Diego
Chula Vista, California, United States, 91911
2
Tower ENT
Los Angeles, California, United States, 90048
3
SENTA Clinic
San Diego, California, United States, 92108
4
Ear, Nose, and Throat Associates of South Florida
Boca Raton, Florida, United States, 33487