Impact of Morning Light Therapy in IBD

Last updated: October 2, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Colic

Crohn's Disease (Pediatric)

Ulcerative Colitis

Treatment

Morning Light Therapy

Clinical Study ID

NCT07207200
STUDY-24-01623
  • Ages > 18
  • All Genders

Study Summary

The pilot study will focus on the effects of morning light therapy (MLT) in adult patients with ulcerative colitis (UC) who have evidence of poor sleep quality and active inflammation. The specific population is at risk for circadian rhythm sleep-wake disorders and has significant potential benefit from circadian realignment, which may lead to improved sleep quality and, ultimately, UC-related inflammatory activity. During an initial one-week lead-in period, participants will obtain baseline circadian-related labs, complete symptom-related surveys, and use a wearable device continuously to obtain baseline sleep-wake data. After the lead-in week, patients will undergo one hour of MLT while wearing wearable devices continuously and completing daily symptom surveys. At the end of four weeks of MLT, patients will obtain post-intervention circadian and inflammatory assessments in addition to completing the same symptom-related surveys.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with ulcerative colitis and signs of inflammation (Fecal calprotectin >150mcg/g and/or CRP >5)

Exclusion

Exclusion Criteria:

  • Known pregnancy or currently lactating women

  • Current malignancy or active treatment for previously diagnosed malignancy. Patientswith squamous and basal cell cancer of the skin are eligible for the study.

  • Serious co-morbidity including: Immunodeficiency, recent myocardial infarction orstroke, history of renal or hepatic failure, infection such as abscess,opportunistic infection, or sepsis.

  • Patients with pacemaker or defibrillators

  • The use of medications known to affect autonomic nervous system function, includingbut not limited to beta-blockers and benzodiazepines.

  • Comprehension of the English language not adequate to understand the questionnaires

  • Recent changes in IBD directed therapies within the last 3 months

  • Regular use of antidiarrheal agents.

  • Regular use of medications that have been shown to impair sleep (e.g. steroids,stimulants). If willing (and medically appropriate) to washout for 4 weeks,participant can be then enrolled in the study

  • Regular use of sleep medications including but not limited to: benzodiazepinehypnotics, non-benzodiazepine hypnotics, antipsychotics, and melatonin. If willing (and medically appropriate) to washout for 4 weeks, participant can be then enrolledin the study

  • Patients with prior colectomy or total proctocolectomy

  • History of any surgery within 3 months

  • Untreated Obstructive Sleep Apnea

  • Blindness or severely impaired, uncorrected vision

  • Employment which includes nocturnal shift work

  • Traveling multiple time zones within the study time frame

  • Any marijuana or illicit drugs use within one month of enrollment or ongoing basis

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Morning Light Therapy
Phase:
Study Start date:
October 01, 2025
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • Mount Sinai Hospital

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

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