Impact of Morning Light Therapy in IBD

The Effects of Morning Light Therapy on IBD Activity and Symptoms

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Device: Morning Light Therapy

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyder Said; Phone Number: 212-824-7786; Email: hyder.said@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Hyder Said; Phone Number: 212-824-7786
      • Principal Investigator: Hyder Said

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult patients with Ulcerative Colitis (UC); Adult patients with ulcerative colitis (UC)	Device: Morning Light Therapy; One hour of morning light therapy each day for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Microbiome assessment	week 4
Change in Morning urine melatonin level	Urine samples at the beginning and end of the study	week 4

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Robert Hirten, MD, Icahn School of Medicine at Mount Sinai; Principal Investigator: Hyder Said, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: September 3, 2025
• First Submitted That Met QC Criteria: October 2, 2025
• First Posted (Actual): October 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases
• Other Study ID Numbers: STUDY-24-01623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no IRB approval to share individual patient data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No