RECRUITING

Alesis OSA-1 Obstructive Sleep Apnea Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-01
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06949969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Suspicion of OSA, known diagnosis of OSA, STOP BANG score of 3 or greater, BMI \>/= 25
  1. * 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.

Contacts and Locations

Study Contact

Terry J Ward, MHA
CONTACT
321-395-6020
terry.ward@photonicausa.com
Rui Esquantiero, MBA
CONTACT
321-395-6016
rui@photonicausa.com

Principal Investigator

Tahir Salmani, MD
PRINCIPAL_INVESTIGATOR
Tri County Primary Care

Study Locations (Sites)

Tri County Primary Care Inc
Cross City, Florida, 32628
United States
Bioresearch Institute, Llc.
Miramar, Florida, 33027
United States
Neo Clinical Trials Research Institute (NCTRI)
Orlando, Florida, 32804
United States

Collaborators and Investigators

Sponsor: Photonica USA, LLC

  • Tahir Salmani, MD, PRINCIPAL_INVESTIGATOR, Tri County Primary Care

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

  • OSA, Sleep Apnea, Alesis OSA1, AHI, LLLT, UltraSlim

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea