Neurostimulation for Sleep Disordered Breathing (SDB)
- Sponsor
- Lunair Medical
- Study ID
- NCT07243405
- Status
- Recruiting
Conditions
- Sleep Apnea
- Sleep Disordered Breathing (SDB)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Neuro stimulator implant — DEVICENeuro stimulator for treating sleep disordered breathing
Study Details
This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
Key Dates
- First listed
- Nov 21, 2025
- Start date
- Jul 30, 2025
- Status verified
- Apr 2025
- Primary completion
- Sep 1, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 45 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Alpha Lunair System implanted subjects
Primary Outcome Measure
Safety Endpoint - assessment of procedure or device related adverse events [ Time Frame: enrollment to 12 months post-implant ]
Central Contacts
- Kris VP, Clinical Operations1-866-675-4430
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