Bright Light Therapy for IBS
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Must not be taking: NSAIDs, Beta blockers, Antibiotics, others
Disqualifiers: Pregnancy, Night shift work, Major organ disease, others
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
The purpose of this research study is to assess whether morning bright light therapy (BLT) using a wearable device called a Re-Timer could potentially improve Irritable Bowel Syndrome (IBS) symptoms and decrease intestinal permeability (leaky gut). Morning bright light therapy will be administrated through a safe-wearable glasses device called a Re-Timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light.
Will I have to stop taking my current medications?
If you regularly use medications that affect intestinal permeability or melatonin, like certain antibiotics, NSAIDs, or sleep aids, you would need to stop taking them 4 weeks before joining the study.
How is Bright Light Therapy different from other treatments for IBS?
Eligibility Criteria
This trial is for individuals with Irritable Bowel Syndrome (IBS), who may also have Klinefelter or Triple X Syndrome. It's not clear what the specific inclusion and exclusion criteria are, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study.Inclusion Criteria
Late chronotype based on the Munich Chronotype Questionnaire (Corrected Midpoint of Sleep > 4:00h)
I am between 18 and 65 years old.
I have been diagnosed with Irritable Bowel Syndrome.
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Exclusion Criteria
Night shift workers or individuals who have crossed more than 2 time zones in the previous 4 weeks
Pregnant or planning to become pregnant
High risk of sleep apnea in 2 or more categories of the Berlin Questionnaire
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive morning bright light therapy (BLT) using Re-Timer glasses or placebo for 2 weeks, followed by a 2-week washout, then crossover to the other condition for another 2 weeks
6 weeks
Assessments at two timepoints: after 2 weeks of BLT and after 2 weeks of placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Bright Light Therapy (Behavioural Intervention)
Trial OverviewThe study is testing if morning bright light therapy using Re-Timer glasses can improve IBS symptoms and reduce leaky gut. Participants will wear these safe, lightweight glasses that emit blue-green light similar to natural sunlight.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Re-Timer Device (Bright Light Therapy)Experimental Treatment1 Intervention
Morning bright light therapy will be administrated through a safe wearable device called a Re-timer. The Re-Timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light. The device emits light at a higher wavelength than the UV range and has a UV filter for added safety. Subjects will be asked to wear the glasses for one hour each morning per day for 7 days a week. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery).
Group II: Placebo device (non Bright Light Therapy)Placebo Group1 Intervention
Subjects will be asked to wear glasses that do not provide Bright Light Therapy for one hour each morning per day for 7 days a week as recommended by the manufacturer. They will wear the device for a total of 14 days to receive the full therapeutic effect. Additionally, subjects will be asked to complete the light therapy the first hour of being awake and remain indoors while using the device. Participants will be informed that they can wear the device freely throughout their home or work environment but should avoid activities that could potentially be harmful (i.e., driving, contact sports, operating heavy machinery).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial. [2023]Photobiomodulation describes the use of red or near-infrared light to stimulate or regenerate tissue. It was discovered that near-infrared wavelengths (800-900 nm) and red (600 nm) light-emitting diodes (LED) are able to penetrate through the scalp and skull and have the potential to improve the subnormal cellular activity of compromised brain tissue. Different experimental and clinical studies were performed to test LED therapy for traumatic brain injury (TBI) with promising results. One of the proposals of this present study is to develop different approaches to maximize the positive effects of this therapy and improve the quality of life of TBI patients.
Broad-spectrum light versus blue light for phototherapy in neonatal hyperbilirubinemia: a randomized controlled trial. [2015]Phototherapy is standard care for treatment of neonatal hyperbilirubinemia. Our aim was to compare the effectiveness of broad-spectrum light (BSL) to that of blue light emitting diodes (LED) phototherapy for the treatment of jaundiced late preterm and term infants. Infants with gestational age from 35(+0) to 41(+6) weeks of gestation and nonhemolytic hyperbilirubinemia were randomized to treatment with BSL phototherapy or blue LED phototherapy. A total of 20 infants were included in the blue LED phototherapy group and 20 in the BSL phototherapy group. The duration of phototherapy was lower in the BSL than in the blue LED phototherapy group (15.8 ± 4.9 vs. 20.6 ± 6.0 hours; p = 0.009), and infants in the former group had a lower probability (p = 0.015) of remaining in phototherapy than infants in the latter. We concluded that BSL phototherapy is more effective than blue LED phototherapy for the treatment of hyperbilirubinemia in late preterm and term infants. Our data suggest that these results are not due to the different irradiance of the two phototherapy systems, but probably depend on their different peak light emissions.
Randomized controlled trial of light-emitting diode phototherapy. [2013]We wished to compare the efficacy of light-emitting diode (LED) phototherapy with special blue fluorescent (BB) tube phototherapy in the treatment of neonatal hyperbilirubinemia.
Photobiomodulation: The Clinical Applications of Low-Level Light Therapy. [2022]Low-level light therapy (LLLT) is a recent addition to the pantheon of light-based therapeutic interventions. The absorption of red/near-infrared light energy, a process termed "photobiomodulation," enhances mitochondrial ATP production, cell signaling, and growth factor synthesis, and attenuates oxidative stress. Photobiomodulation is now highly commercialized with devices marketed directly to the consumer. In the gray area between the commercial and therapeutic sectors, harnessing the clinical potential in reproducible and scientifically measurable ways remains challenging.
The dark art of light measurement: accurate radiometry for low-level light therapy. [2022]Lasers and light-emitting diodes are used for a range of biomedical applications with many studies reporting their beneficial effects. However, three main concerns exist regarding much of the low-level light therapy (LLLT) or photobiomodulation literature; (1) incomplete, inaccurate and unverified irradiation parameters, (2) miscalculation of 'dose,' and (3) the misuse of appropriate light property terminology. The aim of this systematic review was to assess where, and to what extent, these inadequacies exist and to provide an overview of 'best practice' in light measurement methods and importance of correct light measurement. A review of recent relevant literature was performed in PubMed using the terms LLLT and photobiomodulation (March 2014-March 2015) to investigate the contemporary information available in LLLT and photobiomodulation literature in terms of reporting light properties and irradiation parameters. A total of 74 articles formed the basis of this systematic review. Although most articles reported beneficial effects following LLLT, the majority contained no information in terms of how light was measured (73%) and relied on manufacturer-stated values. For all papers reviewed, missing information for specific light parameters included wavelength (3%), light source type (8%), power (41%), pulse frequency (52%), beam area (40%), irradiance (43%), exposure time (16%), radiant energy (74%) and fluence (16%). Frequent use of incorrect terminology was also observed within the reviewed literature. A poor understanding of photophysics is evident as a significant number of papers neglected to report or misreported important radiometric data. These errors affect repeatability and reliability of studies shared between scientists, manufacturers and clinicians and could degrade efficacy of patient treatments. Researchers need a physicist or appropriately skilled engineer on the team, and manuscript reviewers should reject papers that do not report beam measurement methods and all ten key parameters: wavelength, power, irradiation time, beam area (at the skin or culture surface; this is not necessarily the same size as the aperture), radiant energy, radiant exposure, pulse parameters, number of treatments, interval between treatments and anatomical location. Inclusion of these parameters will improve the information available to compare and contrast study outcomes and improve repeatability, reliability of studies.