Evaluation of the Lunair Alpha Neurostimulator Device for Treating Moderate to Severe Sleep Disordered Breathing

What this Trial Is About

Researchers are evaluating the Lunair Alpha System, a neurostimulator device, for its safety and effectiveness in treating moderate to severe sleep disordered breathing, including sleep apnea. This is the first human study of this device, aiming to address treatment challenges for patients who cannot tolerate or comply with existing therapies. The study involves implanting the Lunair Alpha System neurostimulator in participants diagnosed with moderate to severe sleep disordered breathing confirmed by polysomnography PSG. There are no placebo groups or blinding. Participants will be monitored for adverse events from enrollment through 12 months after implant. Secondary outcomes include improvements in sleep disordered breathing assessed by sleep studies at 6, 12, and 24 months post-implant. Participants will undergo evaluations including PSG sleep studies to monitor breathing patterns and safety assessments for device- or procedure-related adverse events. Researchers will track changes in breathing during sleep and overall sleep quality over two years. The total study duration includes long-term follow-up to evaluate sustained safety and effectiveness of the implanted neurostimulator device.

Neurostimulation for Sleep Disordered Breathing