Alesis OSA-1 Obstructive Sleep Apnea Treatment

NCT06949969 | Completed FDA Device

• 1 other identifier: IORG0012434
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• AHI Events

  Apnea-hypoapnea events will be documented on the at home OSA sleep study (WatchPat) device. The number of AHI events occurring pre and post treatment will be evaulated for improvement;

  From enrollment until the end of treatment at 3 weeks.

Secondary Outcomes (2)

• Fat and tissue volume reduction

  From enrollment to the end of treatment at 3 weeks

• Pulmonary Functions Volumes

  From enrollment to end of treatment in 3 weeks

Study Arms (4)

Alesis OSA-1 Effectivness

ACTIVE COMPARATOR

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.

Device: OSA LLLT treatment device

MRI Assessment

NO INTERVENTION

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.

PFT Assessment

NO INTERVENTION

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.

OSA-1 Control group

PLACEBO 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.

Device: Sham Comparator

Interventions

OSA LLLT treatment device 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.

Alesis OSA-1 Effectivness

Sham Comparator DEVICE

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.

OSA-1 Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Photonica USA, LLC: lead

Study Sites (2)

JD Medical Group, LLC

Miami, Florida, 33133, United States

Location

Bioresearch Institute, Llc.

Miramar, Florida, 33027, United States

Location

Related Publications (10)

• Medical Advisory Secretariat. Polysomnography in patients with obstructive sleep apnea: an evidence-based analysis. Ont Health Technol Assess Ser. 2006;6(13):1-38. Epub 2006 Jun 1.

  PMID: 23074483 BACKGROUND

• Sutherland K, Lowth AB, Antic N, Carney AS, Catcheside PG, Chai-Coetzer CL, Chia M, Hodge JC, Jones A, Kaambwa B, Lewis R, MacKay S, McEvoy RD, Ooi EH, Pinczel AJ, McArdle N, Rees G, Singh B, Stow N, Weaver EM, Woodman RJ, Woods CM, Yeo A, Cistulli PA. Volumetric magnetic resonance imaging analysis of multilevel upper airway surgery effects on pharyngeal structure. Sleep. 2021 Dec 10;44(12):zsab183. doi: 10.1093/sleep/zsab183.

  PMID: 34283220 BACKGROUND

• Wang SH, Keenan BT, Wiemken A, Zang Y, Staley B, Sarwer DB, Torigian DA, Williams N, Pack AI, Schwab RJ. Effect of Weight Loss on Upper Airway Anatomy and the Apnea-Hypopnea Index. The Importance of Tongue Fat. Am J Respir Crit Care Med. 2020 Mar 15;201(6):718-727. doi: 10.1164/rccm.201903-0692OC.

  PMID: 31918559 BACKGROUND

• Orestes MI, Tuchayi SM, Wang Y, Farinelli W, Arkun K, Anderson RR, Thomas R, Garibyan L. Safety and feasibility of selective tongue fat reduction with injected ice-slurry. Laryngoscope Investig Otolaryngol. 2022 Sep 9;7(5):1675-1680. doi: 10.1002/lio2.902. eCollection 2022 Oct.

  PMID: 36258870 BACKGROUND

• Kirsch DB. Obstructive Sleep Apnea. Continuum (Minneap Minn). 2020 Aug;26(4):908-928. doi: 10.1212/CON.0000000000000885.

  PMID: 32756228 BACKGROUND

• Guo J, Xiao Y. New Metrics from Polysomnography: Precision Medicine for OSA Interventions. Nat Sci Sleep. 2023 Mar 9;15:69-77. doi: 10.2147/NSS.S400048. eCollection 2023.

  PMID: 36923968 BACKGROUND

• Kennedy J, Verne S, Griffith R, Falto-Aizpurua L, Nouri K. Non-invasive subcutaneous fat reduction: a review. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1679-88. doi: 10.1111/jdv.12994. Epub 2015 Feb 9.

  PMID: 25664493 BACKGROUND

• Moon IJ, Choi JW, Jung CJ, Kim S, Park E, Won CH. Efficacy and safety of a novel combined 1060-nm and 635-nm laser device for non-invasive reduction of abdominal and submental fat. Lasers Med Sci. 2022 Feb;37(1):505-512. doi: 10.1007/s10103-021-03288-z. Epub 2021 Apr 2.

  PMID: 33797649 BACKGROUND

• Caruso-Davis MK, Guillot TS, Podichetty VK, Mashtalir N, Dhurandhar NV, Dubuisson O, Yu Y, Greenway FL. Efficacy of low-level laser therapy for body contouring and spot fat reduction. Obes Surg. 2011 Jun;21(6):722-9. doi: 10.1007/s11695-010-0126-y.

  PMID: 20393809 BACKGROUND

• Avci P, Nyame TT, Gupta GK, Sadasivam M, Hamblin MR. Low-level laser therapy for fat layer reduction: a comprehensive review. Lasers Surg Med. 2013 Aug;45(6):349-57. doi: 10.1002/lsm.22153. Epub 2013 Jun 7.

  PMID: 23749426 BACKGROUND

Related Links

• Clinical trial for LLLT in body contouring and fat reduction
• 510K clearance for body contouring, fat reduction, inflammation, and skin tightening. Ultraslim rebranded as Alesis OSA-1

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Carlos Perez, MD

  JD Medical Group, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will compare two groups, a control group which will receive a simulated 12 minute treatment that does not expose the participant to LLLT and a treatment group who will receive a 12 minute treatment using LLLT. The Alesis OSA-1 device is a branded UltraSlim Digital device that uses narrowband 635nm noncoherent light to immediately reduce fat volume. The device has three 510(k) FDA clearances (K160880, K150336, and K202361).

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 29, 2025
• Study Start: May 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be available starting three months after after the study completion date and for one full year (end date).
• Access Criteria: Researchers conducting similar or related studies can request the information by contacting the primary study contract in email or writing. They will receive a de-identified excel file that is password protected.

Locations

US (2)