Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403644
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-22
Brief Title:
Evaluating the Technology and Assessing the Biological Effects of Commercially Available PhotoBioModulation Devices
Sponsor:
United States Air Force Research Laboratory
Organization:
United States Air Force Research Laboratory
Study Overview
Official Title:
Evaluating the Technology and Assessing the Biological Effects of Commercially Available PhotoBioModulation Devices
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PBMTs 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 Veterans 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 70mWcm2 and low-power PBMT 30mWcm2 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 11 to a high-power PBM ARRC-LED or low-power PBM NovoTHOR treatment group Then participants will subsequently be randomized 11 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
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 11 to a high-power PBM ARRC-LED or low-power PBM NovoTHOR treatment group Then participants will subsequently be randomized 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None