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Behavioural Intervention
Bright Light Therapy for IBS
N/A
Recruiting
Led By Caitlin Green
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18-65 years old
Diagnosed with Irritable Bowel Syndrome based on Rome IV diagnostic criteria
Must not have
Diagnosis of narrow angle glaucoma or retinal disorders, or demonstrated symptoms indicative of these diagnoses during eligibility screening
Presence of any major organ disease such as known renal impairment, diabetes, liver disease, significant cardiac failure (NY classification stage III/IV), inflammatory bowel disease, or celiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks of morning bright light therapy (blt)
Summary
This trial aims to see if using a wearable device called Re-Timer, which emits blue-green light therapy in the morning, can help improve symptoms of Irritable Bowel Syndrome (IBS) and
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While side effects are not detailed here, bright light therapy can sometimes cause eye strain, headache, nausea, irritability or sleep disturbances in some people.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I have been diagnosed with Irritable Bowel Syndrome.
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I have IBS with symptoms that are at least mild in severity.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with or shown symptoms of narrow angle glaucoma or retinal disorders.
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I do not have major organ diseases like kidney, liver issues, severe heart failure, or severe digestive conditions.
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I have moderate to severe depression.
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My restless leg syndrome is severe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks of morning bright light therapy (blt)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks of morning bright light therapy (blt)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Aim 1a
Aim 1b
Secondary study objectives
Aim 2
Trial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Re-Timer glasses
2015
N/A
~20
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,374 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
973 Previous Clinical Trials
7,399,354 Total Patients Enrolled
Caitlin GreenPrincipal InvestigatorMedical University of South Carolina
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