A Randomized Crossover Trial of Bright Light Therapy in Crohn's Disease on Intestinal Barrier Homeostasis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT05579392
Status
Recruiting
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Conditions

  • Inflammatory Bowel Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bright Light Therapy — DEVICE
    Device: Bright Light Therapy Retimer
  • Placebo Retimer Device — DEVICE
    Device: Placebo Retimer Device with no bright light therapy

Study Details

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).

Key Dates

Start date
Sep 22, 2022
Status verified
Jun 2026
Primary completion
Sep 1, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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)

Primary Outcome Measure

Changes in intestinal permeability (% excretion of urinary sucralose) [ Time Frame: 15 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60068
Daynia Sanchez-Bass
[email protected]
312-563-4981
Medical University of South CarolinaCharlestonSouth Carolina29425
Katy Donovan
[email protected]
843-792-7974
Garth Swanson, M.D., M.S (PRINCIPAL_INVESTIGATOR)

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