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 range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
Trial details
NCT IDNCT06403644
SponsorUnited States Air Force Research Laboratory