Alesis OSA-1 Double-Blinded Randomized Study of Obstructive Sleep Apnea Treatment Using A Patented Noncoherent Medical Light

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Suspicion of OSA, known diagnosis of OSA, STOP BANG score of 3 or greater, BMI \>/= 25

Locations
United States
Florida
JD Medical Group, LLC
RECRUITING
Miami
Bioresearch Institute, Llc.
RECRUITING
Miramar
Contact Information
Primary
Terry J Ward, MHA
terry.ward@photonicausa.com
321-395-6020
Backup
Rui Estanqueiro, MBA
rui@photonicausa.com
321-395-6016
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 70
Treatments
Active_comparator: Alesis OSA-1 Effectivness
The treatment group of the study will receive LLLT from the previously FDA 501(k) class I approved Ultraslim device, now rebranded under the name Alesis OSA-1. N=35 participants will receive non-invasive LLLT at 635nm wavelength for 12 minutes, 2x per week, x 3 weeks.~The Alesis OSA-2 device will be used for this arm of the study.
No_intervention: MRI Assessment
5 participants from the treatment group will be randomly selected to receive to pre and post magnetic resonance imaging (MRI) on the head/neck to determine change in size or volume of soft tissue and fat within the airway/neck structures.
No_intervention: PFT Assessment
Ten participants, 5 from the treatment group and 5 from control, will receive pre and post study pulmonary function testing (PFT) to evaluate changes in pulmonary volumes related the treatments.
Placebo_comparator: OSA-1 Control group
A modified device utilizing a pigtail connector to bypass active treatment while allowing the cooling fans to operate for the treatment period, giving the appearance of treatment with invisible light.
Related Therapeutic Areas
Sponsors
Leads: Photonica USA, LLC

This content was sourced from clinicaltrials.gov