Recruiting

Morning Light Therapy

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07207200

Conditions

Inflammatory Bowel Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Morning Light Therapy

Study Details

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 ID

NCT07207200

Start date

Mar, 2026

Status verified date

Mar, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Adult patients with Ulcerative Colitis (UC)

Adult patients with ulcerative colitis (UC)

Interventions

Morning Light Therapy

One hour of morning light therapy each day for four weeks

Primary outcome measure

  • C-reactive protein (CRP) level [ Time Frame: week 4 ]
  • Fecal Calprotectin (FCP) [ Time Frame: week 4 ]

Central Contacts and Locations

Central contacts

Hyder Said

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

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Hyder Said

212-824-7786

Principal Investigator:

Hyder Said

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-03-13.