Impact of Morning Light Therapy in IBD

NCT07207200 | Recruiting

• 1 other identifier: STUDY-24-01623
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Patient-Reported Outcomes Measurement Information System (PROMIS 10)

  week 4

• Change in Microbiome composition

  week 4

• Change in Morning urine melatonin level

  week 4

Study Arms (1)

Adult patients with Ulcerative Colitis (UC)

EXPERIMENTAL

Adult patients with ulcerative colitis (UC)

Device: Morning Light Therapy

Interventions

Morning Light Therapy DEVICE

One hour of morning light therapy each day for four weeks

Adult patients with Ulcerative Colitis (UC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Hyder Said

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Robert Hirten, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyder Said

CONTACT

212-824-7786; hyder.said@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: One hour of morning light therapy each day for four weeks

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: October 3, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)