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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with Ulcerative Colitis (UC) | Experimental | Adult patients with ulcerative colitis (UC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morning Light Therapy | Device | One hour of morning light therapy each day for four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 4 |
| Fecal Calprotectin (FCP) | The fecal calprotectin is a stool test which measures intestinal inflammation. | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 4 |
| Change in Microbiome composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyder Said | Contact | 212-824-7786 | hyder.said@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Hyder Said | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Robert Hirten, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
There is no IRB approval to share individual patient data
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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One hour of morning light therapy each day for four weeks
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Microbiome assessment
| week 4 |
| Change in Morning urine melatonin level | Urine samples at the beginning and end of the study | week 4 |