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

Not Applicable

Recruiting

• Conditions: Physiological Wellness

• Registration Number: NCT06403644
• Lead Sponsor: United States Air Force Research Laboratory

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.

Study Timeline

• Study Start: 2024-03-11
• Study First Submitted: 2024-03-22
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08
• Primary Completion: 2028-03-11
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Effects of PBMT versus Sham PBMT on Proinflammatory Blood Biomarkers	Through study completion, an average of 8 weeks.	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.
Effects of PBMT versus Sham PBMT on Anti-Inflammatory Blood Biomarkers	Through study completion, an average of 8 weeks.	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.
Effects of PBMT versus Sham PBMT on Saliva Biomarkers	Through study completion, an average of 8 weeks.	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.
Effects of PBMT versus Sham PBMT on Heart Rate	Through study completion, an average of 8 weeks.	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.
Effects of PBMT versus Sham PBMT on Defense Veterans Pain Rating Scale Scores	Through study completion, an average of 8 weeks.	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.
Effects of PBMT versus Sham PBMT on Athletic Mental Energy Scale Scores	Through study completion, an average of 8 weeks.	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.
Effects of PBMT versus Sham PBMT on Epworth Sleepiness Scale Scores	Through study completion, an average of 8 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Effects of using PBMT Light Beds at Different Power Intensities on Saliva Biomarkers	Through study completion, an average of 8 weeks.	Changes in saliva biomarkers (cytokine panel: IL-1 Beta, IL-6, IL-8 \& TNF-alpha) compared across high-power and low-power PBMT. As elevated proinflammatory cytokines may be a sign of heightened inflammation, lower cytokine levels in saliva samples may indicate a more ideal treatment outcome.
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.	Differences in self reported Defense Veterans Pain Rating Scale scores compared across low-power and high-power PBMT treatment. 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.
Effects of using PBMT Light Beds at Different Power Intensities on Heart Rate	Through study completion, an average of 8 weeks.	Acute heart rate variability differences within a single treatment session and trends across treatment weeks compared across low-power and high-power PBMT treatment.
Effects of using PBMT Light Beds at Different Power Intensities on Athletic Mental Energy Scale Scores	Through study completion, an average of 8 weeks.	Differences in self reported Athletic Mental Energy Scale scores compared across low-power and high-power PBMT treatment. 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).
Effects of using PBMT Light Beds at Different Power Intensities on Anti-Inflammatory Blood Biomarkers	Through study completion, an average of 8 weeks.	Changes in blood biomarkers (MSD anti-inflammatory panel: IL-4, IL-10) compared across low-power and high-power PBMT. As elevated anti-inflammatory cytokine levels may be a sign of lowered inflammation, higher anti-inflammatory cytokine levels may indicate a more ideal treatment outcome.
Effects of using PBMT Light Beds at Different Power Intensities on Proinflammatory Blood Biomarkers	Through study completion, an average of 8 weeks.	Changes in blood biomarkers (MSD proinflammatory panel: IL-1beta, IL-2, IL-6, IL-12p70, IL-17A, IFN-gamma, and TNF-alpha) compared across low-power and high-power PBMT. As elevated proinflammatory cytokine levels may be a sign of heightened inflammation, lower proinflammatory cytokine levels may indicate a more ideal treatment outcome.
Effects of using PBMT Light Beds at Different Power Intensities on Epworth Sleepiness Scale Scores	Through study completion, an average of 8 weeks.	Differences in self reported Epworth Sleepiness Scale scores compared across low-power and high-power PBMT treatment. 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.

Trial Locations

Locations (1)

Wright Patterson Air Force Base; 🇺🇸 Beavercreek, Ohio, United States