Alesis OSA-1 Obstructive Sleep Apnea Treatment

Launched by PHOTONICA USA, LLC · Apr 22, 2025

Keywords

ClinConnect Summary

The Alesis OSA-1 Obstructive Sleep Apnea Treatment trial is studying a new device that uses low laser light therapy to help reduce symptoms of obstructive sleep apnea (OSA) in adults. This trial will involve participants who are at least 18 years old and have been diagnosed with OSA. The main goal is to see if using the Alesis OSA-1 device can lower the number of breathing interruptions (measured by the apnea-hypopnea index, or AHI) after six treatments, each lasting 12 minutes, over three weeks.

Eligible participants will include those who have a known diagnosis of OSA, a specific screening score (STOP BANG) of 3 or more, and a body mass index (BMI) of 25 or higher. They will visit a clinic to be assessed and learn how to use a sleep study system called WatchPat to measure their AHI events before and after treatment. Participants will receive six sessions of therapy, lying under the device for short periods. Those who are in the control group will not receive treatment during the study but may be offered the therapy afterward. It's important to note that certain health conditions or factors, like recent surgeries or specific medications, may prevent someone from participating in the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Suspicion of OSA, known diagnosis of OSA, STOP BANG score of 3 or greater, BMI \>/= 25
• Exclusion Criteria:
• • Beard or facial hair, diagnosis of central sleep apnea, inability to hold mouth open 12 minutes, Age less than 18 years old, • Severe comorbid conditions that may affect treatment or inability to lie flat or sit for 20 minutes (e.g., severe cardiac disease, uncontrolled diabetes); Contraindications to MRI (e.g., non-MRI-compatible pacemakers); History of recent upper airway surgery; Active cancer or cancer treatment completion within 1 year; Contraindications to LLLT such as systemic lupus erythematosis (SLE); Photosensitivity; Pregnancy; Renal disease; Facial fillers within 3 months; Diabetes medications (light sensitivity) Sulfonylurea medications, Metformin, Sitagliptin; Liver disease; Autoimmune disorders; Albinism; Antibiotic therapy-Tetracyclines, Fluoroquinolones (ciprofloxacin, ofloxacin, levofloxacin); Sulfonamides, Tricyclic antidepressants.