Evaluating the Technology and Assessing the Biological Effects of Commercially Available PhotoBio… (NCT06403644) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluating the Technology and Assessing the Biological Effects of Commercially Available PhotoBioModulation Devices
United States41 participantsStarted 2024-03-11
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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)
What they're measuring
1
Effects of PBMT versus Sham PBMT on Proinflammatory Blood Biomarkers
Timeframe: Through study completion, an average of 8 weeks.
2
Effects of PBMT versus Sham PBMT on Anti-Inflammatory Blood Biomarkers
Timeframe: Through study completion, an average of 8 weeks.
3
Effects of PBMT versus Sham PBMT on Saliva Biomarkers
Timeframe: Through study completion, an average of 8 weeks.
4
Effects of PBMT versus Sham PBMT on Heart Rate
Timeframe: Through study completion, an average of 8 weeks.
5
Effects of PBMT versus Sham PBMT on Defense Veterans Pain Rating Scale Scores
Timeframe: Through study completion, an average of 8 weeks.
6
Effects of PBMT versus Sham PBMT on Athletic Mental Energy Scale Scores
Timeframe: Through study completion, an average of 8 weeks.
7
Effects of PBMT versus Sham PBMT on Epworth Sleepiness Scale Scores
Timeframe: Through study completion, an average of 8 weeks.
Trial details
NCT IDNCT06403644
SponsorUnited States Air Force Research Laboratory