Evaluating the Technology and Assessing the Biological Effects of Commercially Available PhotoBioModulation Devices

United States Air Force Research Laboratory

Status: Enrolling

Conditions: Physiological Wellness

Treatments: Device: ARRC LED Photobiomodulation Full Body Light Bed; Device: NovoTHOR XL Photobiomodulation Full Body Light Bed

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06403644

FWR20230189H

Details and patient eligibility

About

Photobiomodulation therapy (PBMT) involves applying non-ionizing forms of light from sources including lasers, LEDs, and broadband light, in the visible and near infrared spectrum, to the body to enhance performance, stimulate healing, modulate recovery, and improve health. The investigators will conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT in a military population, translating this cutting-edge research to application in the operational setting.

Full description

In addition to assessing the efficacy of whole-body PBMT in comparison to sham therapy, the human subjects PBM study conducted encompasses a comprehensive data collection endeavor aimed at evaluating PBMT's impact on general wellness. Using a single-blinded randomized control trial design, participants are assigned to different treatment groups and subjected to PBMT or sham treatments over specified periods. Randomization ensures unbiased assignment to treatment groups, and participants are blinded to their assigned study arm until the conclusion of the final study visit. Detailed treatment protocols are followed, including precautions to minimize bias between active and sham treatments. Data collection includes an extensive array of both subjective and physiological measures, encompassing tools such as the Defense and Veteran's Pain Rating Scale (DVPRS), Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), heart rate monitors, blood samples, and saliva samples. Additionally, this study investigates the differences between high-power PBMT (~70mW/cm2) and low-power PBMT (~30mW/cm2) by a secondary randomization of participants into one of two commercial PBMT light beds (either the NovoTHOR or ARRC LED).

The study is conducted over an 8-week period and separated into two arms. Participants that meet final eligibility criteria will be randomized to a study arm following informed consent using a computer-generated randomization model. Participants will first be randomized (1:1) to a high-power PBM (ARRC-LED) or low-power PBM (NovoTHOR) treatment group. Then participants will subsequently be randomized (1:1) to a treatment schedule (either sham or active treatment first). The initial week of the study consists of a washout week in which baseline data is collected. In Part 1 (Weeks 2-4), participants undergo photobiomodulation treatment sessions or sham photobiomodulation treatment sessions lasting 20 minutes, occurring 3 times a week for 3 weeks. Following Part 1, Week 5 consists of an additional washout period. During this 1-week period, participants will continue daily study procedures, including questionnaires, saliva collection, and wearing the Oura Ring, but will not receive sham or active PBMT. In Part 2 (Weeks 6-8), participants will resume treatment sessions crossing over into the other condition (either sham or active PBMT), also lasting 20 minutes and occurring 3 times a week for 3 weeks. Overall, the human subjects experiment works to provide valuable insights into the practical applications and potential benefits of PBMT.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Active-duty military personnel, government civilians, and government contractors
2. Between the ages of 18-45 years old (inclusive)
3. Ability to read and understand English language
4. Willingness and ability to commit to study procedures, including study intervention and follow-up

Exclusion criteria

1. Body fat > 40%
2. Weight exceeds 300lbs
3. Height exceeds 7ft 3in
4. > 10% of full body coverage of tattoos
5. Cardiovascular disease requiring medical management
6. Currently utilizing a pacemaker
7. Currently utilizing select medications (e.g., statins, diuretics, antihypertensive agents)
8. Currently utilizing medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
9. Currently undergoing treatment for a brain-related injury
10. Diagnosis of autoimmune diseases
11. Diagnosis of porphyria (light induced allergy) or photosensitive eczema
12. Diagnosis of Cancer
13. Diagnosis of epilepsy and/or being seizure prone
14. Diagnosis of diabetes
15. Diagnosis of Lupus Erythematosus
16. Diagnosis of retinal disease
17. Uncontrolled thyroid disease (known problem with no medical management)
18. Cirrhosis of the liver
19. Impaired blood clotting (from medication or underlying condition)
20. Photophobia
21. Albinism/achromasia
22. Currently pregnant or plan to become pregnant during the study (6 weeks)
23. Currently participating in any other intervention-based research studies other than protocol FWR20220097H that may confound results.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Active Photobiomodulation Full Body Light Bed Therapy

Active Comparator group

Description:

Active treatment will be provided via a specialized full body light bed equipped with light-emitting diodes (LEDs) emitting specific wavelengths of light. The participant will be asked to lay in the bed for a 20-minute session. Treatment will be provided 3 times a week for 3 weeks.

Treatment:

Device: NovoTHOR XL Photobiomodulation Full Body Light Bed

Device: ARRC LED Photobiomodulation Full Body Light Bed

Sham Photobiomodulation Full Body Light Bed Therapy

Sham Comparator group

Description:

Sham-PBMT will be delivered in the same manner as indicated for the Active treatment process, but the devices will not be turned on. The participant will be asked to lay in a specialized full body light bed equipped with light-emitting diodes (LEDs) for a 20-minute session. Sham-PBMT Treatment will be provided 3 times a week for 3 weeks.

Treatment:

Device: NovoTHOR XL Photobiomodulation Full Body Light Bed

Device: ARRC LED Photobiomodulation Full Body Light Bed