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Behavioral Intervention

Morning Light Treatment for Inflammatory Bowel Disease

N/A

Recruiting

Led By Helen Burgess, Ph.D.

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-proven IBD

Age >/=18 years old

Must not have

High risk for or diagnosed with obstructive sleep apnea, and/or narcolepsy

Retinal pathology, history of eye surgery, taking photosensitizing medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-treatment approximately 36 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if changes to sleep and light can improve IBD symptoms.

Who is the study for?

This trial is for adults over 18 with biopsy-proven inflammatory bowel disease (IBD) who speak English and can travel for study visits. They should have active IBD symptoms and a reduced quality of life due to IBD. Excluded are those with acute suicidal thoughts, certain gastrointestinal surgeries, pregnancy or breastfeeding, recent night work or travel, other serious chronic diseases, eye conditions or surgery, photosensitizing medication use, recent light treatment history, severe mental health disorders including psychotic or bipolar disorder within a lifetime diagnosis; substance abuse in the past three months; high risk of sleep apnea/narcolepsy; severe hearing issues; intellectual disabilities or significant cognitive impairments.

What is being tested?

The study is examining if adjusting sleep patterns and using morning light therapy can improve symptoms in people with ulcerative colitis and Crohn's disease. Participants will either continue their usual treatments without changes (treatment-as-usual) or receive additional morning light treatment to see if there's an effect on their IBD symptoms.

What are the potential side effects?

While not explicitly stated for this trial since it involves non-pharmaceutical interventions like sleep timing adjustments and morning light therapy, potential side effects may include discomfort from changing sleep habits and mild eye strain or headache from the light treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My inflammatory bowel disease (IBD) was confirmed through a biopsy.

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I am 18 years old or older.

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My disease is currently causing symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am at high risk for or have been diagnosed with sleep apnea or narcolepsy.

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I have eye conditions, had eye surgery, or take medication that increases light sensitivity.

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I am planning to have or have had surgery related to my bowel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-treatment approximately 36 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-treatment approximately 36 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-treatment approximately 36 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Short IBD Questionnaire (SIBDQ) score

Secondary study objectives

Change in Patient Health Questionnaire 9 (PHQ-9) score

Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS) Short-Form 8b

For patients with Crohn's Disease (CD) - Change in Harvey Bradshaw Index (HBI)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Morning light treatmentExperimental Treatment1 Intervention

A 1 hour per day morning light treatment starting at average wake time, or up to 1 hour earlier to accommodate the morning schedule. The daily treatment continues for 4 weeks.

Group II: Treatment-as-usualActive Control1 Intervention

Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks.

0 / 6Eligibility criteria met