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

NCT06403644 | Active Not Recruiting FDA Device

• 1 other identifier: FWR20230189H
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiological Wellness

Keywords

Photobiomodulation; Recovery; Wellness

Outcome Measures

Primary Outcomes (7)

• Effects of PBMT versus Sham PBMT on Proinflammatory Blood Biomarkers

  Changes in blood biomarkers (MSD proinflammatory panel: IL-1beta, IL-2, IL-6, IL-12p70, IL-17A, IFN-gamma, and TNF-alpha) compared across the sham and active PBMT conditions. As elevated proinflammatory cytokine levels may be a sign of heightened inflammation, lower proinflammatory cytokine levels at the end of the active condition compared to the beginning of the block, along with no statistical change at the end of the sham block condition compared to the beginning of the sham block, may indicate a more ideal treatment outcome.

  Through study completion, an average of 8 weeks.

• Effects of PBMT versus Sham PBMT on Anti-Inflammatory Blood Biomarkers

  Changes in blood biomarkers (MSD anti-inflammatory panel: IL-4, IL-10) compared across the sham and active PBMT conditions. As elevated anti-inflammatory cytokine levels may be a sign of lowered inflammation, higher anti-inflammatory cytokine levels at the end of the active condition compared to the beginning of the block, along with no statistical change at the end of the sham block condition compared to the beginning of the sham block, may indicate a more ideal treatment outcome.

  Through study completion, an average of 8 weeks.

• Effects of PBMT versus Sham PBMT on Saliva Biomarkers

  Changes in saliva biomarkers (cytokine panel: IL-1 Beta, IL-6, IL-8 \& TNF-alpha) compared across the sham and active PBMT conditions. As elevated proinflammatory cytokines may be a sign of heightened inflammation, lower cytokine levels in saliva samples at the end of the active condition compared to the beginning of the block, along with no statistical change at the end of the sham block condition compared to the beginning of the sham block, may indicate a more ideal treatment outcome.

  Through study completion, an average of 8 weeks.

• Effects of PBMT versus Sham PBMT on Heart Rate

  Acute heart rate variability differences within a single treatment session and trends across treatment weeks compared to sham PBMT. Higher heart rate variability and/or lower resting heart rate during active PBMT may indicate a more ideal treatment outcome.

  Through study completion, an average of 8 weeks.

• Effects of PBMT versus Sham PBMT on Defense Veterans Pain Rating Scale Scores

  Differences in self reported Defense Veterans Pain Rating Scale (DVPRS) scores during active PBMT weeks are compared with baseline and sham PBMT weeks. The Defense Veterans Pain Rating Scale is a 0-10 color coded scale where green represents mild pain with a scale ranging from 0-4; yellow represents moderate pain with a scale ranging from 5-6, and red represents severe pain with a scale ranging from 7-10. Lower DVPRS scores in active PBMT conditions when compared to sham conditions would indicate a more ideal treatment outcome.

  Through study completion, an average of 8 weeks.

• Effects of PBMT versus Sham PBMT on Athletic Mental Energy Scale Scores

  Differences in self reported Athletic Mental Energy Scale (AMES) scores during active PBMT weeks are compared with baseline and sham PBMT weeks. The Athletic Mental Energy Scale comprises 18 items measuring athletes' perception of their energy state, including vigor, confidence, motivation, tirelessness, concentration, and calm. Participants rate their feelings on a 6-point Likert scale (1 = not at all, 6 = completely so). Higher AMES scores in active PBMT conditions when compared to sham conditions could indicate a more ideal treatment outcome.

  Through study completion, an average of 8 weeks.

• Effects of PBMT versus Sham PBMT on Epworth Sleepiness Scale Scores

  Differences in self reported Epworth Sleepiness Scale scores during active PBMT weeks are compared with baseline and sham PBMT weeks. The Epworth Sleepiness Scale results range from 0 to 24. Results from 0 to 10 show average (normal) daytime sleepiness, results under 10 may not be cause for concern or could identify trouble sleeping (insomnia), 11 to 24 indicates excessive (abnormal) daytime sleepiness. Lower Epworth Sleepiness Scale Scores scores in active PBMT conditions when compared to sham conditions could indicate a more ideal treatment outcome.

  Through study completion, an average of 8 weeks.

Secondary Outcomes (7)

• Effects of using PBMT Light Beds at Different Power Intensities on Anti-Inflammatory Blood Biomarkers

  Through study completion, an average of 8 weeks.

• Effects of using PBMT Light Beds at Different Power Intensities on Proinflammatory Blood Biomarkers

  Through study completion, an average of 8 weeks.

• Effects of using PBMT Light Beds at Different Power Intensities on Saliva Biomarkers

  Through study completion, an average of 8 weeks.

• Effects of using PBMT Light Beds at Different Power Intensities on Heart Rate

  Through study completion, an average of 8 weeks.

• Effects of using PBMT Light Beds at Different Power Intensities on Defense Veterans Pain Rating Scale Scores

  Through study completion, an average of 8 weeks.

Study Arms (2)

Active Photobiomodulation Full Body Light Bed Therapy

ACTIVE COMPARATOR

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.

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

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.

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

Interventions

NovoTHOR XL Photobiomodulation Full Body Light Bed 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.

Active Photobiomodulation Full Body Light Bed Therapy; Sham Photobiomodulation Full Body Light Bed Therapy

ARRC LED Photobiomodulation Full Body Light Bed 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.

Active Photobiomodulation Full Body Light Bed Therapy; Sham Photobiomodulation Full Body Light Bed Therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Body fat \> 40%
• Weight exceeds 300lbs
• Height exceeds 7ft 3in
• \> 10% of full body coverage of tattoos
• Cardiovascular disease requiring medical management
• Currently utilizing a pacemaker
• Currently utilizing select medications (e.g., statins, diuretics, antihypertensive agents)
• Currently utilizing medications associated with sensitivity to heat or light (e.g., amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
• Currently undergoing treatment for a brain-related injury
• Diagnosis of autoimmune diseases
• Diagnosis of porphyria (light induced allergy) or photosensitive eczema
• Diagnosis of Cancer
• Diagnosis of epilepsy and/or being seizure prone
• Diagnosis of diabetes
• Diagnosis of Lupus Erythematosus

Sponsors & Collaborators

• United States Air Force Research Laboratory: lead
• The Geneva Foundation: collaborator
• Uniformed Services University of the Health Sciences: collaborator
• Ohio State University: collaborator

Study Sites (1)

Wright Patterson Air Force Base

Beavercreek, Ohio, 45324, United States

Location

Related Publications (6)

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

  PMID: 34947870 BACKGROUND

• 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.

  PMID: 25844681 BACKGROUND

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

  PMID: 30044464 BACKGROUND

• 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.

  PMID: 33232629 BACKGROUND

• 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.

  PMID: 26610637 BACKGROUND

• 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.

  PMID: 27624781 BACKGROUND

Study Officials

• Jason Eckerle

  United States Air Force Research Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: To prevent possible bias between the sham and active conditions, both groups will receive light filtering glasses (to control for light perception), noise-cancelling headphones, and be in a controlled temperature room.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: May 8, 2024
• Study Start: March 11, 2024
• Primary Completion: December 19, 2025
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)