Morning light therapy for ulcerative colitis with poor sleep
The Effects of Morning Light Therapy on IBD Activity and Symptoms
This pilot will test whether one hour of morning light therapy can improve sleep and lower inflammation in adults with ulcerative colitis who have poor sleep and signs of active inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07207200 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with ulcerative colitis who have poor sleep quality and objective active inflammation (fecal calprotectin >150 mcg/g and/or CRP >5), who can attend Mount Sinai visits and are not on excluded medications or recent changes in IBD therapy.
Not a fit: Patients without poor sleep or without objective inflammatory activity, pregnant or lactating individuals, those with certain serious comorbidities or implanted cardiac devices, or those taking excluded medications or with recent IBD treatment changes are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could improve sleep quality and reduce UC-related inflammation, potentially reducing symptoms and lowering flare risk.
How similar studies have performed: Morning light therapy has improved circadian alignment and sleep in other conditions, but using it specifically to reduce intestinal inflammation in UC is a novel and largely untested application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.