Status:
NOT_YET_RECRUITING
Impact of Morning Light Therapy in IBD
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 po...
Eligibility Criteria
Inclusion
- Patients with ulcerative colitis and signs of inflammation (Fecal calprotectin \>150 mcg/g and/or CRP \>5)
Exclusion
- Known pregnancy or currently lactating women
- Current malignancy or active treatment for previously diagnosed malignancy. Patients with squamous and basal cell cancer of the skin are eligible for the study.
- Serious co-morbidity including: Immunodeficiency, recent myocardial infarction or stroke, 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, including but 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: benzodiazepine hypnotics, non-benzodiazepine hypnotics, antipsychotics, and melatonin. If willing (and medically appropriate) to washout for 4 weeks, participant can be then enrolled in 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07207200
Start Date
October 1 2025
End Date
July 1 2027
Last Update
October 3 2025
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029