Alesis OSA-1 for Obstructive Sleep Apnea
(OSA Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it excludes participants on certain medications like diabetes medications (e.g., Metformin) and some antibiotics. It's best to discuss your specific medications with the trial coordinators.
What data supports the effectiveness of the treatment Alesis OSA-1 for obstructive sleep apnea?
What is the purpose of this trial?
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 of 18 who are diagnosed with obstructive sleep apnea (OSA). The main questions it aims to answer are\]:• Does the use of the Alesis OSA-1 device reduce the number of AHI events after six treatments of 12 minutes each, 2x per week x 3 weeks, in adult OSA patients?Researchers will compare results of 35 control group participants who will not receive treatment to a treatment group who will receive six, 12 minute, non-invasive low laser light therapy (LLLT) treatments, two per week for 3 weeks, to see if there is a reduction in the number of AHI events and size of redundant and soft tissues in adult OSA patients.Participants will:* Visit the clinic for assessment and instructions on using the at home sleep study system, WatchPat, and obtain baseline information* Use the WatchPat system to record AHI events pre- and post-treatment.* 10 randomly selected participants will receive a pre-study pulmonary functions test (PFT) and repeated post-treatment.* 5 randomly selected participant will receive a pre-study MRI of the head/neck and repeated post treatment.* For the treatments, the participant lie on a treatment table under a LLLT device for 12 minutes, two times per week, x 3 weeks.* Be offered the treatment series at the conclusion of the study if they were selected for the control group.
Research Team
Tahir Salmani, MD
Principal Investigator
Tri County Primary Care
Eligibility Criteria
Adults over 18 with obstructive sleep apnea (OSA) can join this trial. They must be diagnosed with OSA and able to follow the study's treatment schedule. People are excluded if they have conditions that might interfere with the trial or make it unsafe for them.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive six, 12-minute non-invasive low laser light therapy treatments, two times per week for 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including post-treatment AHI test and qualitative questionnaire
Open-label extension (optional)
Control group participants are offered the treatment series at the conclusion of the study if results demonstrate a reduction in AHI events
Treatment Details
Interventions
- Alesis OSA-1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Photonica USA, LLC
Lead Sponsor