Impact of Morning Light Therapy in IBD

Mount Sinai Health System

Status

Not yet enrolling

Conditions

Inflammatory Bowel Disease

Treatments

Device: Morning Light Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07207200

STUDY-24-01623

Details and patient eligibility

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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