A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis
Not applicable · Testing Bright Light Therapy · 2 sites · Rush University Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Bright Light Therapy (a device) to better understand how the disease works. Condition(s) listed: Inflammatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Biopsy proven diagnosis of Crohn's or Ulcerative Colitis
- 18 years or older
- Fecal Calprotectin > 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50
Plus 1 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2022-09-22.
- Main results expected around 2026-09-01 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in United States.
Main thing being measured
- Changes in intestinal permeability (% excretion of urinary sucralose) (15 weeks)
In the researchers’ words
Crohn's Disease (CD) and Ulcerative Colitis (UC), collectively known as inflammatory bowel disease (IBD), are two of the most significant chronic conditions of the gastrointestinal tract (GIT) and affects over 1.5 million individuals in the U.S. Recently, there has been an increased understanding of the importance of sleep and sleep disruption in IBD as a potentially modifiable risk factor.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease |
| Lead sponsor | Rush University Medical Center |
| Enrollment | 30 (estimated) |
| Start date | 2022-09-22 |
| Primary completion (est.) | 2026-09-01 |
| First posted | 2022-10-13 |
| Last updated | 2026-06-09 |
| Official title | Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis |
| ClinicalTrials.gov ID | NCT05579392 |
Interventions
- Bright Light Therapy (Device)
Device: Bright Light Therapy Retimer - Placebo Retimer Device (Device)
Device: Placebo Retimer Device with no bright light therapy
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Biopsy proven diagnosis of Crohn's or Ulcerative Colitis 2. 18 years or older 3. Fecal Calprotectin > 50 or CRP above upper limit of normal or a PROMISE Fatigue ≥ 50 4. Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks Exclusion Criteria: 1. Active IBD (Harvey Bradshaw Index > 5 or Modified Harvey Bradshaw Index >5) 2. Major depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression) 3. Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43) 4. Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44)) 5. Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blockers, psychotropic medications, hypnotics and exogenous melatonin products during 4 weeks prior to the study 6. People who have worked night shifts or crossed more than 2 time zones in the previous month 7. Any major organ disease - renal impairment (creatinine>1.2 mg/dL), diabetes (Hgb-A1c > 6.5%); liver disease (LFTs > 1.5x normal), or significant cardiac failure (NY classification stage III/IV) 8. Diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening 9. Inability to sign an informed consent
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Rush University Medical Center | Chicago, Illinois | United States | Recruiting |
| Medical University of South Carolina | Charleston, South Carolina | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.