Evaluating the Technology and Assessing the Biological Effects of Commercially Available PhotoBioModulation Devices
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Effects of PBMT versus Sham PBMT on Proinflammatory Blood Biomarkers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Diagnosis of retinal disease
- •Uncontrolled thyroid disease (known problem with no medical management)
- •Cirrhosis of the liver
- •Impaired blood clotting (from medication or underlying condition)
- •Photophobia
- •Albinism/achromasia
- •Currently pregnant or plan to become pregnant during the study (6 weeks)
- •Currently participating in any other intervention-based research studies other than protocol FWR20220097H that may confound results.
研究组 & 干预措施
Active Photobiomodulation Full Body Light Bed Therapy
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.
干预措施: NovoTHOR XL Photobiomodulation Full Body Light Bed (Device)
Active Photobiomodulation Full Body Light Bed Therapy
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.
干预措施: ARRC LED Photobiomodulation Full Body Light Bed (Device)
Sham Photobiomodulation Full Body Light Bed Therapy
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.
干预措施: NovoTHOR XL Photobiomodulation Full Body Light Bed (Device)
Sham Photobiomodulation Full Body Light Bed Therapy
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.
干预措施: ARRC LED Photobiomodulation Full Body Light Bed (Device)
结局指标
主要结局
Effects of PBMT versus Sham PBMT on Proinflammatory Blood Biomarkers
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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 Defense Veterans Pain Rating Scale Scores(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 Athletic Mental Energy Scale Scores(Through study completion, an average of 8 weeks.)
- 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 Epworth Sleepiness Scale Scores(Through study completion, an average of 8 weeks.)
研究者
Jason Eckerle
Principal Investigator
United States Air Force Research Laboratory