Light Therapy for Good Health

Overseen By Margaret E Hollander

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Air Force Research Laboratory

Must not be taking: Statins, Diuretics, Antihypertensives, others

Disqualifiers: Cardiovascular disease, Cancer, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how photobiomodulation (PBMT), a type of light therapy, can improve health and recovery in a military setting. Participants will receive either active light therapy using a special LED bed or a sham (inactive) treatment for comparison. The goal is to determine if this therapy can enhance performance, accelerate healing, and aid recovery. The trial seeks active-duty military personnel, government civilians, and contractors who can commit to the study process. As an unphased trial, participants have the opportunity to contribute to groundbreaking research that could benefit military health and recovery.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications, such as statins, diuretics, antihypertensive agents, and those associated with sensitivity to heat or light. If you are on these medications, you may need to stop them to participate.

What prior data suggests that photobiomodulation therapy is safe?

Research has shown that photobiomodulation therapy (PBMT) is generally safe. This therapy uses red and near-infrared light, which is non-invasive and drug-free. Studies indicate that this light therapy is well-tolerated when used correctly.

However, very strong light may rarely cause skin redness or blisters. The therapy does not have known toxic effects, especially with short-term use. Following the recommended guidelines ensures the safest experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Photobiomodulation Therapy because it offers a unique, non-invasive approach to improving health by using light. Unlike standard treatments that might involve medications or surgeries, this therapy uses a full body light bed equipped with LEDs to emit specific wavelengths of light, potentially stimulating healing and wellness. What sets it apart is its innovative delivery method, which involves simply lying in a bed for short sessions, making it an easy and accessible option for participants. Additionally, the potential for light to influence cellular processes offers a novel mechanism of action that could complement or enhance existing treatments.

What evidence suggests that photobiomodulation therapy is effective for enhancing performance and improving health?

Research shows that photobiomodulation therapy (PBMT), which participants in this trial may receive, can help reduce pain. Studies have found it effective for easing pain from conditions like knee pain, osteoarthritis, and post-surgical pain. Beyond pain relief, other research suggests that red light therapy, a type of PBMT, might also improve skin health by reducing wrinkles, scars, and redness. Evidence even indicates it can aid hair growth. Although more research is needed, these early findings are promising for those considering this therapy. ^{4 5 6 7 8}

Who Is on the Research Team?

Jason Eckerle

Principal Investigator

United States Air Force Research Laboratory

Are You a Good Fit for This Trial?

This trial is for healthy individuals, likely within a military population based on the description. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and be willing to undergo light therapy treatments.

Inclusion Criteria

Active-duty military personnel, government civilians, and government contractors

Ability to read and understand English language

I am willing and able to follow the study's procedures and attend all follow-up visits.

Exclusion Criteria

I have been diagnosed with an autoimmune disease.

Weight exceeds 300lbs

Height exceeds 7ft 3in

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Washout and Baseline Data Collection

Baseline data is collected during a washout week where participants do not receive any treatment.

1 week

1 visit (in-person)

Treatment Part 1

Participants undergo photobiomodulation treatment sessions or sham treatment sessions, 3 times a week for 3 weeks.

3 weeks

9 visits (in-person)

Washout

Participants continue daily study procedures without receiving sham or active PBMT.

1 week

1 visit (in-person)

Treatment Part 2

Participants resume treatment sessions, crossing over into the other condition (either sham or active PBMT), 3 times a week for 3 weeks.

3 weeks

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Photobiomodulation Therapy

Trial Overview The study is testing two types of full-body light beds: NovoTHOR XL and ARRC LED, which use non-ionizing light to potentially enhance performance and stimulate healing. It's a single-blinded study with some people getting real treatment and others getting sham (fake) treatment as control.

How Is the Trial Designed?

Group I: Active Photobiomodulation Full Body Light Bed Therapy Active Control 2 Interventions

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.

Group II: Sham Photobiomodulation Full Body Light Bed Therapy Placebo Group 2 Interventions

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.

Photobiomodulation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in European Union as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Approved in Canada as Photobiomodulation Therapy for:

• Pain relief
• Tissue repair
• Inflammation reduction
• Wound healing

Who Is Running the Clinical Trial?

United States Air Force Research Laboratory

Lead Sponsor

Trials

3

Recruited

310+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

Low-level laser therapy (LLLT) has a positive effect on bone regeneration, particularly when there is an optimal relationship between the dose and output power used, as shown in a review of 19 studies.

LLLT stimulates cellular metabolism and increases protein synthesis, which contributes to enhanced bone regeneration, especially when using a high dose with low power or a low dose with high power.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low-Level Laser Therapy on Bone Regeneration During Osseointegration and Bone Graft. Zein, R., Selting, W., Benedicenti, S.[2018]

Low-level light therapy (LLLT) has been shown to be a safe and effective treatment for skin rejuvenation, acne vulgaris, and body contouring, supported by a reasonable amount of clinical trial evidence.

Despite its commercial success, the quality of evidence for LLLT is limited by methodological flaws and small sample sizes, highlighting the need for more rigorous, independent clinical trials to validate its therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. Glass, GE.[2022]

Low level laser therapy (LLLT) can increase the proliferation of cancer cells, as shown in a study using osteosarcoma and lung carcinoma cell lines, indicating potential risks when used in dental treatments.

The study found that the proliferation rates of cancer cells increased with both the power output of the laser and the number of applications, suggesting that LLLT could inadvertently activate precancerous cells or exacerbate existing cancerous tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy induces increased viability and proliferation in isolated cancer cells. Kara, C., Selamet, H., Gökmenoğlu, C., et al.[2022]

Low-level laser therapy (LLLT) shows promise as a non-invasive treatment for inflammatory diseases, particularly for skin and joint conditions, due to its anti-inflammatory effects and ability to stimulate tissue repair with minimal side effects.

Despite its potential, the variability in laser application methods and a lack of standardized studies on laser type and dosage create challenges in fully understanding and implementing LLLT effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser Light Therapy in Inflammatory, Musculoskeletal, and Autoimmune Disease. Wickenheisser, VA., Zywot, EM., Rabjohns, EM., et al.[2020]

Low-level light therapy (LLLT) shows promising benefits in periodontal and dental implant treatments, demonstrating biostimulatory, anti-inflammatory, and analgesic effects that can enhance healing and reduce inflammation.

Despite the positive findings, there is significant variability in study designs and light irradiation parameters, making it difficult to establish standardized evidence-based protocols for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation in Periodontology and Implant Dentistry: Part 1. Gholami, L., Asefi, S., Hooshyarfard, A., et al.[2020]

Low-level laser therapy (LLLT) effectively reduces pain and promotes healing by using coherent light in the 600 to 1000 nm wavelength range, which triggers biochemical changes in cells and has been supported by numerous clinical and experimental studies.

LLLT has shown significant analgesic and anti-inflammatory effects, making it a promising complementary treatment option for managing symptoms in patients with osteoarthritis and chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Literature on Low-level Laser Therapy Benefits for Nonpharmacological Pain Control in Chronic Pain and Osteoarthritis. Dima, R., Tieppo Francio, V., Towery, C., et al.[2019]

Low level light/laser therapy (LLLT) shows promise for treating oral and dental disorders, with 130 out of 153 reviewed studies reporting positive effects such as pain relief and faster healing.

LLLT is considered a safe and novel approach for oral applications, suggesting it could address unmet clinical needs in dental care, although its use in this area has been limited compared to other medical fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in low level light therapy (LLLT) for dentistry. Carroll, JD., Milward, MR., Cooper, PR., et al.[2022]

Low level laser therapy (LLLT) effectively promotes tissue repair and reduces inflammation, making it a valuable tool for enhancing wound healing.

LLLT works by regulating cell behavior through light, influencing cell proliferation and the release of bioactive substances, which contributes to its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advancement in the research of effect of low level laser therapy on wound healing]. Mao, HS., Yao, M., Fang, Y.[2015]

Low level laser therapy (LLLT) has been widely used and accepted in Eastern Europe and Asia for various medical conditions, indicating its perceived efficacy among clinicians and patients.

Despite its popularity and reported clinical benefits, LLLT has not yet undergone thorough evaluation through randomized clinical trials in North America and Australasia, highlighting a need for more rigorous research to assess its true value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It is time to test low level laser therapy in Great Britain. Moshkovska, T., Mayberry, J.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9980499/

Low-intensity LASER and LED (photobiomodulation ... There is evidence that photobiomodulation therapy reduces pain intensity in non-specific knee pain, osteoarthritis, pain post-total hip arthroplasty, ...

2. med.stanford.edu med.stanford.edu/news/insights/2025/02/red-light-therapy-skin-hair-medical-clinics.html

Red light therapy: What the science says - Stanford Medicine Instead, they found that those receiving red light treatment sprouted more hair. Additional studies — in mice and in humans — bolstered evidence ...

3. my.clevelandclinic.org my.clevelandclinic.org/health/articles/22114-red-light-therapy

Red Light Therapy: Benefits, Side Effects & Uses Red light therapy uses low levels of red light to reportedly improve your skin's appearance, such as reducing wrinkles, scars, redness and acne.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3926176/

A Controlled Trial to Determine the Efficacy of Red and ... The purpose of this study was to investigate the safety and efficacy of two novel light sources for large area and full body application.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05146596

The Effectiveness of Using Low-level Light Therapy to ... The purpose of this study is to explore the treatment of Low Level Light Therapy(LLLT) mitigate possible insomnia and psychological symptoms, when nurses have ...

6. lightforcemedical.com lightforcemedical.com/is_photobiomodulation_therapy_safe/

Is Photobiomodulation Therapy Safe? What the Research ... Photobiomodulation therapy is safe, non-invasive, and drug-free. It uses specific wavelengths of red and near-infrared light to stimulate the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11503318/

Photobiomodulation as Medicine: Low-Level Laser Therapy ... Under FDA regulations, a 510(k) application is required for new LLLT device clearance [7]. Market authorization by regulators includes ...

8. webmd.com webmd.com/skin-problems-and-treatments/red-light-therapy

Red Light Therapy: Effectiveness, Treatment, and Risks Red light therapy is generally safe, but at very high strengths of light, skin redness and blistering can occur. How much weight can you lose ...