Morning light therapy for ulcerative colitis with poor sleep

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot interventional study enrolls adults with ulcerative colitis who have poor sleep and objective evidence of inflammation. Participants complete a one-week lead-in with baseline circadian and inflammatory labs, symptom surveys, and continuous wearable sleep-wake monitoring. After the lead-in, participants receive one hour of morning light therapy daily for four weeks while continuing wearable monitoring and daily symptom surveys. At the end of the four-week intervention, circadian and inflammatory assessments and the same symptom surveys are repeated to compare pre- and post-treatment measures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Where it's running

• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Hyder Said — Icahn School of Medicine at Mount Sinai
• Study coordinator: Hyder Said
• Email: hyder.said@mountsinai.org
• Phone: 212-824-7786

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.