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NCT Number: NCT07207200

Impact of Morning Light Therapy in IBD

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

New York, 10029, United States

Location status: Recruiting

Location contact

Hyder Said

CONTACT

212-824-7786

Hyder Said

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morning Light Therapy

Device

One hour of morning light therapy each day for four weeks

Primary outcomes

  1. C-reactive protein (CRP) level

    Time frame: week 4

    C-reactive protein (CRP) is produced by the liver. The CRP test is a general test to check for inflammation in the body.

  2. Fecal Calprotectin (FCP)

    Time frame: week 4

    The fecal calprotectin is a stool test which measures intestinal inflammation.

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS 10)

    Time frame: week 4

    A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults.

  2. Change in Microbiome composition

    Time frame: week 4

    Microbiome assessment

  3. Change in Morning urine melatonin level

    Time frame: week 4

    Urine samples at the beginning and end of the study

Study contacts

Contact information is provided by the study sponsor or research team.

Hyder Said

CONTACT

[email protected]

212-824-7786

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

The Effects of Morning Light Therapy on IBD Activity and Symptoms

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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