Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07207200

Impact of Morning Light Therapy in IBD

Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-03-13

30

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Impact of Morning Light Therapy in IBD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with ulcerative colitis and signs of inflammation (Fecal calprotectin >150 mcg/g and/or CRP >5)
Not Eligible

You will not qualify if you...

  • Known pregnancy or currently lactating women
  • Current malignancy or active treatment for previously diagnosed malignancy, except squamous and basal cell skin cancers
  • 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
  • Use of medications that affect autonomic nervous system function, including beta-blockers and benzodiazepines
  • Inadequate comprehension of English to understand questionnaires
  • Recent changes in IBD therapies within the last 3 months
  • Regular use of antidiarrheal agents
  • Regular use of medications known to impair sleep such as steroids or stimulants unless willing and medically able to washout for 4 weeks
  • Regular use of sleep medications including benzodiazepine hypnotics, non-benzodiazepine hypnotics, antipsychotics, and melatonin unless willing and medically able to washout for 4 weeks
  • 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 involving night shift work
  • Traveling across multiple time zones during the study period
  • Use of marijuana or illicit drugs within one month of enrollment or ongoing

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

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Research Team

H

Hyder Said

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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