Inflammatory Bowel DiseaseNCT07207200
Impact of Morning Light Therapy in IBD
A study testing Morning Light Therapy in people with Inflammatory Bowel Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Morning Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ulcerative colitis and signs of inflammation (Fecal calprotectin >150 mcg/g and/or CRP >5)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Hyder Said, 212-824-7786
Hyder Said
About this study
Official title: 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.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Morning Light Therapy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning Light TherapyDevice
One hour of morning light therapy each day for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with Ulcerative Colitis (UC) | Experimental | Adult patients with ulcerative colitis (UC) Receives: Device: Morning Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 4
Fecal Calprotectin (FCP)
The fecal calprotectin is a stool test which measures intestinal inflammation.
Measured: week 4
Secondary outcomes (3)
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.
Measured: week 4
Change in Microbiome composition
Microbiome assessment
Measured: week 4
Change in Morning urine melatonin level
Urine samples at the beginning and end of the study
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One hour of morning light therapy each day for four weeks
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Hirten, Icahn School of Medicine at Mount Sinai
- Investigators
- Hyder Said, Principal investigator, Icahn School of Medicine at Mount SinaiRobert Hirten, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207200
- Sponsor's protocol ID
- STUDY-24-01623
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IRB approval to share individual patient data