About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients with ulcerative colitis and signs of inflammation (Fecal calprotectin >150 mcg/g and/or CRP >5)
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Morning Light Therapy
DeviceOne hour of morning light therapy each day for four weeks
Treatment groups
Trial outcomes
Primary outcomes
C-reactive protein (CRP) level
C-reactive protein (CRP) is produced by the liver. The CRP test is a general test to check for inflammation in the body.
Fecal Calprotectin (FCP)
The fecal calprotectin is a stool test which measures intestinal inflammation.
Secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS 10)
A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults.
Change in Microbiome composition
Microbiome assessment
Change in Morning urine melatonin level
Urine samples at the beginning and end of the study
Sponsors and contacts
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