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Behavioural Intervention
Bright Light Therapy for Crohn's Disease
N/A
Recruiting
Led By Netanel Zilberstein
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 weeks
Summary
This trial evaluates whether light therapy can help people with IBD reduce inflammation, improve gut health and improve quality of life. FDA-approved device will be used and participants will wear a watch-like device to monitor their condition.
Who is the study for?
This trial is for adults with Crohn's or Ulcerative Colitis who have stable inflammatory markers and have been on consistent medication for their condition. It excludes those with active IBD, major organ disease, recent night shift work or extensive travel, certain eye diseases, severe depression, sleep apnea, restless leg syndrome, or use of drugs affecting intestinal permeability.
What is being tested?
The study tests if bright light therapy in the morning can help people with Crohn's Disease by reducing gut inflammation and improving quality of life compared to a placebo device. Participants will switch between the real treatment and placebo at some point during the trial.
What are the potential side effects?
Bright Light Therapy may cause eyestrain or headache. Since it involves exposure to intense light early in the day, it might also affect sleep patterns temporarily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hematuria
Body Weight Changes
Secondary study objectives
Inflammation
Inflammation
Trial Design
2Treatment groups
Experimental Treatment
Group I: No Bright Light Therapy via placebo glasses, Then Bright Light TherapyExperimental Treatment2 Interventions
Participants will wear their placebo device for 60 minutes every morning for 28-days (4 weeks)
Group II: Bright Light Therapy via ReTimer glasses, Then PlaceboExperimental Treatment2 Interventions
Participants will wear their device for 60 minutes every morning for 28-days (4 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bright Light Therapy
2010
Completed Early Phase 1
~60
Find a Location
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
249,334 Total Patients Enrolled
Netanel ZilbersteinPrincipal InvestigatorRush University Medical Center
Ali Keshavarzian, M.D.Principal InvestigatorRush University Medical Center
1 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a biopsy-confirmed diagnosis of Crohn's disease or Ulcerative Colitis.I have signs of inflammation according to my tests.I do not have severe kidney, liver, diabetes, or heart failure issues.My inflammatory bowel disease is under control.I haven't taken drugs affecting gut health or sleep hormones in the last 4 weeks.I am unable to understand or sign the consent form.I am 18 years old or older.My restless leg syndrome is severe.I have been on a consistent dose of my medication for at least 12 weeks.I have major depression with a high score or thoughts of suicide.I have been diagnosed with or show symptoms of narrow angle glaucoma or retinal disorders.
Research Study Groups:
This trial has the following groups:- Group 1: No Bright Light Therapy via placebo glasses, Then Bright Light Therapy
- Group 2: Bright Light Therapy via ReTimer glasses, Then Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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