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

NCT ID: NCT06403644

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2028-09-01

Brief Summary

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.

Detailed 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.

Conditions

Physiological Wellness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Active Photobiomodulation Full Body Light Bed Therapy

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.

Group Type: ACTIVE_COMPARATOR

NovoTHOR XL Photobiomodulation Full Body Light Bed

Intervention Type: DEVICE

Low powered full-body photobiomodulation light bed therapy will be administered via the NovoTHOR XL light therapy bed which emits an average irradiance of \~30 mW/cm\^2.

ARRC LED Photobiomodulation Full Body Light Bed

Intervention Type: DEVICE

High powered full-body photobiomodulation light bed therapy will be administered via the ARRC LED light therapy bed which emits an average irradiance of \~75 mW/cm\^2.

Sham Photobiomodulation Full Body Light Bed Therapy

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.

Group Type: SHAM_COMPARATOR

NovoTHOR XL Photobiomodulation Full Body Light Bed

Intervention Type: DEVICE

Low powered full-body photobiomodulation light bed therapy will be administered via the NovoTHOR XL light therapy bed which emits an average irradiance of \~30 mW/cm\^2.

ARRC LED Photobiomodulation Full Body Light Bed

Intervention Type: DEVICE

High powered full-body photobiomodulation light bed therapy will be administered via the ARRC LED light therapy bed which emits an average irradiance of \~75 mW/cm\^2.

Interventions

NovoTHOR XL Photobiomodulation Full Body Light Bed

Low powered full-body photobiomodulation light bed therapy will be administered via the NovoTHOR XL light therapy bed which emits an average irradiance of \~30 mW/cm\^2.

Intervention Type: DEVICE

ARRC LED Photobiomodulation Full Body Light Bed

High powered full-body photobiomodulation light bed therapy will be administered via the ARRC LED light therapy bed which emits an average irradiance of \~75 mW/cm\^2.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

The Geneva Foundation

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

United States Air Force Research Laboratory

FED

Sponsor Role: lead

Responsible Party

Jason Eckerle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Eckerle

Role: PRINCIPAL_INVESTIGATOR

United States Air Force Research Laboratory

Locations

Wright Patterson Air Force Base

Beavercreek, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Margaret E Hollander

Role: CONTACT

Mhollander@Genevausa.org

7038634124

Facility Contacts

Margaret E Hollander

Role: primary

Mhollander@Genevausa.org

703-863-4124

Joshua Hagen

Role: backup

hagen.112@osu.edu

References

Ailioaie LM, Litscher G. Photobiomodulation and Sports: Results of a Narrative Review. Life (Basel). 2021 Dec 3;11(12):1339. doi: 10.3390/life11121339.

Reference Type: BACKGROUND

PMID: 34947870 (View on PubMed)

Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015 Apr;33(4):183-4. doi: 10.1089/pho.2015.9848. No abstract available.

Reference Type: BACKGROUND

PMID: 25844681 (View on PubMed)

Heiskanen V, Hamblin MR. Photobiomodulation: lasers vs. light emitting diodes? Photochem Photobiol Sci. 2018 Aug 8;17(8):1003-1017. doi: 10.1039/c8pp90049c.

Reference Type: BACKGROUND

PMID: 30044464 (View on PubMed)

Rossato M, Dellagrana RA, Sakugawa RL, Baroni BM, Diefenthaeler F. Dose-Response Effect of Photobiomodulation Therapy on Muscle Performance and Fatigue During a Multiple-Set Knee Extension Exercise: A Randomized, Crossover, Double-Blind Placebo-Controlled Trial. Photobiomodul Photomed Laser Surg. 2020 Dec;38(12):758-765. doi: 10.1089/photob.2020.4820. Epub 2020 Nov 24.

Reference Type: BACKGROUND

PMID: 33232629 (View on PubMed)

Tumilty S, Mani R, Baxter GD. Photobiomodulation and eccentric exercise for Achilles tendinopathy: a randomized controlled trial. Lasers Med Sci. 2016 Jan;31(1):127-35. doi: 10.1007/s10103-015-1840-4. Epub 2015 Nov 26.

Reference Type: BACKGROUND

PMID: 26610637 (View on PubMed)

de Paiva PR, Tomazoni SS, Johnson DS, Vanin AA, Albuquerque-Pontes GM, Machado CD, Casalechi HL, de Carvalho PT, Leal-Junior EC. Photobiomodulation therapy (PBMT) and/or cryotherapy in skeletal muscle restitution, what is better? A randomized, double-blinded, placebo-controlled clinical trial. Lasers Med Sci. 2016 Dec;31(9):1925-1933. doi: 10.1007/s10103-016-2071-z. Epub 2016 Sep 13.

Reference Type: BACKGROUND

PMID: 27624781 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

FWR20230189H

Identifier Type: -

Identifier Source: org_study_id