Status:
RECRUITING
Alesis OSA-1 Obstructive Sleep Apnea Treatment
Lead Sponsor:
Photonica USA, LLC
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of randomized clinical trial is to determine if the Alesis OSA-1 low laser light therapy device can reduce apnea-hypopnea index scores and treat sleep apnea in adult participants over the age...
Detailed Description
PURPOSE To evaluate the efficacy of the non-invasive Alesis Low-Level Light Therapy (LLLT) medical device in treating obstructive sleep apnea (OSA) by assessing changes in upper airway fat deposits vi...
Eligibility Criteria
Inclusion
- Suspicion of OSA, known diagnosis of OSA, STOP BANG score of 3 or greater, BMI \>/= 25
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06949969
Start Date
May 1 2025
End Date
October 1 2025
Last Update
July 28 2025
Active Locations (2)
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1
JD Medical Group, LLC
Miami, Florida, United States, 33133
2
Bioresearch Institute, Llc.
Miramar, Florida, United States, 33027