Clinical trial NCT06403644: Evaluating the Technology and Assessing the Biological Effects of Commercially Available PhotoBioModulation Devices
Official title: Evaluating the Technology and Assessing the Biological Effects of Commercially Available PhotoBioModulation Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physiological Wellness
Keywords: Photobiomodulation
Recovery
Wellness
Lead sponsor: United States Air Force Research Laboratory
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
name: The Geneva Foundation
name: Ohio State University
First posted: 2024-05-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will have two 3-week periods of treatment with a washout week in-between treatment. Participants will be randomized to either sham PBM treatment or active PBM treatment first.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Effects of PBMT versus Sham PBMT on Proinflammatory Blood Biomarkers
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of PBMT versus Sham PBMT on Anti-Inflammatory Blood Biomarkers
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of PBMT versus Sham PBMT on Saliva Biomarkers
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of PBMT versus Sham PBMT on Heart Rate
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of PBMT versus Sham PBMT on Defense Veterans Pain Rating Scale Scores
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of PBMT versus Sham PBMT on Athletic Mental Energy Scale Scores
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of PBMT versus Sham PBMT on Epworth Sleepiness Scale Scores
timeFrame: Through study completion, an average of 8 weeks.
Secondary outcomes:
measure: Effects of using PBMT Light Beds at Different Power Intensities on Anti-Inflammatory Blood Biomarkers
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of using PBMT Light Beds at Different Power Intensities on Proinflammatory Blood Biomarkers
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of using PBMT Light Beds at Different Power Intensities on Saliva Biomarkers
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of using PBMT Light Beds at Different Power Intensities on Heart Rate
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of using PBMT Light Beds at Different Power Intensities on Defense Veterans Pain Rating Scale Scores
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of using PBMT Light Beds at Different Power Intensities on Athletic Mental Energy Scale Scores
timeFrame: Through study completion, an average of 8 weeks.
measure: Effects of using PBMT Light Beds at Different Power Intensities on Epworth Sleepiness Scale Scores
timeFrame: Through study completion, an average of 8 weeks.
Other outcomes:
Locations:
city: Beavercreek
country: United States
facility: Wright Patterson Air Force Base
state: Ohio
Study officials:
affiliation: United States Air Force Research Laboratory
name: Jason Eckerle
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ailioaie LM, Litscher G. Photobiomodulation and Sports: Results of a Narrative Review. Life (Basel). 2021 Dec 3;11(12):1339. doi: 10.3390/life11121339.
citation: 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.
citation: Heiskanen V, Hamblin MR. Photobiomodulation: lasers vs. light emitting diodes? Photochem Photobiol Sci. 2018 Aug 8;17(8):1003-1017. doi: 10.1039/c8pp90049c.
citation: 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.
citation: 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.
citation: 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.