Recruiting

Bright Light Therapy

Sponsor:

Rush University Medical Center

Code:

NCT05579392

Conditions

Inflammatory Bowel Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bright Light Therapy

Placebo Retimer Device

Study Details

Brief summary:

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. We, therefore, hypothesize that intervening with morning bright light therapy (BLT) in IBD patients with CM will decrease intestinal permeability and pro-inflammatory cytokines, positively impact intestinal microbiota, and improve quality of life (QoL).

Conditions

Inflammatory Bowel Disease

Study ID

NCT05579392

Start date

Sep 22, 2022

Status verified date

Jun, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Bright Light Therapy via ReTimer glasses, Then Placebo

Participants will wear their device for 60 minutes every morning for 28-days (4 weeks)

experimental: No Bright Light Therapy via placebo glasses, Then Bright Light Therapy

Participants will wear their placebo device for 60 minutes every morning for 28-days (4 weeks)

Interventions

Bright Light Therapy

Device: Bright Light Therapy Retimer

Placebo Retimer Device

Device: Placebo Retimer Device with no bright light therapy

Primary outcome measure

  • Changes in intestinal permeability (% excretion of urinary sucralose) [ Time Frame: 15 weeks ]
  • Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA [ Time Frame: 15 weeks ]

Central Contacts and Locations

Central contacts

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60068

Contacts

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Garth Swanson, M.D., M.S

More Information

Sponsor

Rush University Medical Center

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-06-09.