Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Purpose
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.
Conditions
- Obstructive Sleep Apnea
- OSA
- Apnea
- Apnea, Obstructive
- Apnea, Obstructive Sleep
- Apnea+Hypopnea
- Hypopnea, Sleep
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of moderate to severe OSA - Declines to use or does not tolerate PAP therapy
Exclusion Criteria
- Respiratory, cardiac, renal disease or other co-morbid conditions - BMI > 35 kg/m2 - Specific PSG criteria outlined in the protocol
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- All subjects are implanted and randomized. Stimulation treatment started at M1 for the Active group and M7 +1day for the Control group. Both groups followed through M13.
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- PSG results are masked from the Investigator and Outcomes Assessor.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Active |
HGN therapy activation at Month 1 - compared at Month 7 to Control group, continued stimulation through Month 13 |
|
|
Other 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 |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- LivaNova
Detailed Description
All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit. 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.