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Alesis OSA-1 Obstructive Sleep Apnea Treatment

NCT06949969 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

OSA LLLT treatment device

The Alesis OSA-1 is a LLLT that uses 635nm wavelength to stimulate the mitochondria to open cell spaces and allow oils, lipids, and fluids to drain into the body systems.

DEVICE

Sham Comparator

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.

Sponsors & Collaborators

  • Photonica USA, LLC

    lead INDUSTRY

Principal Investigators

  • Carlos Perez, MD · JD Medical Group, LLC

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-11-30
Completion
2025-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06949969 on ClinicalTrials.gov