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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

About this trial

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).

Eligibility criteria

Qualifiers

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

Has been on a stable dose of either a biologic, immunomodulator, or 5-ASA for at least 12 weeks

Disqualifiers

Active IBD (Harvey Bradshaw Index > 5 or Modified Harvey Bradshaw Index >5)

Major depression (score ≥ 21 or any endorsement of suicidal intent on the Beck Depression)

Sleep apnea (score high risk in 2 or more categories of the Berlin Questionnaire) (43)

Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44))

Trial design

Treatments tested in this trial

  • Bright Light Therapy
  • Placebo Retimer Device

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators