Impact of Morning Light Therapy in IBD

NCT ID: NCT07207200

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-07-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Adult patients with Ulcerative Colitis (UC)

Adult patients with ulcerative colitis (UC)

Group Type: EXPERIMENTAL

Morning Light Therapy

Intervention Type: DEVICE

One hour of morning light therapy each day for four weeks

Interventions

Morning Light Therapy

One hour of morning light therapy each day for four weeks

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Robert Hirten

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyder Said

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Robert Hirten, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Hospital

New York, New York, United States

Countries

United States

Central Contacts

Hyder Said

Role: CONTACT

hyder.said@mountsinai.org

212-824-7786

Other Identifiers

STUDY-24-01623

Identifier Type: -

Identifier Source: org_study_id