Alesis OSA-1 Obstructive Sleep Apnea Treatment
NCT: NCT06949969 · COMPLETED
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 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.
Frequently Asked Questions
What is Alesis OSA-1 Obstructive Sleep Apnea Treatment?
Alesis OSA-1 Obstructive Sleep Apnea Treatment is a clinical trial registered under NCT06949969. Current status: COMPLETED.
What is the status of NCT06949969?
The current status of NCT06949969 (Alesis OSA-1 Obstructive Sleep Apnea Treatment) is: COMPLETED.
When did Alesis OSA-1 Obstructive Sleep Apnea Treatment start?
Alesis OSA-1 Obstructive Sleep Apnea Treatment started on 2025-05-01.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.