Trials / Active Not Recruiting
Active Not RecruitingNCT04950894
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- LivaNova · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
- Obstructive Sleep Apnea
- OSA
- Apnea
- Apnea, Obstructive
- Apnea, Obstructive Sleep
- Apnea+Hypopnea
- Hypopnea, Sleep
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hypoglossal Nerve Stimulation | Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day) |
Timeline
- Start date
- 2021-07-27
- Primary completion
- 2024-10-30
- Completion
- 2025-10-30
- First posted
- 2021-07-06
- Last updated
- 2025-05-01
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04950894. Inclusion in this directory is not an endorsement.