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Behavioral Intervention

Morning Light Treatment for Inflammatory Bowel Disease

N/A
Recruiting
Led By Cathy Goldstein, M.D., M.S.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-treatment approximately 36 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Short IBD Questionnaire (SIBDQ) score
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,524 Total Patients Enrolled
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,070 Total Patients Enrolled
Cathy Goldstein, M.D., M.S.Principal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for participation in this experiment?

"According to the clinicaltrials.gov website, this specific medical trial is no longer seeking patients for enrollment. This investigation was first published on November 1st 2023 with its last update taking place on October 16th 2023. While access is not available through this study, 488 other ongoing trials are actively recruiting participants at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
Helen Burgess 2024. "IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06094608.
All > Inflammatory Bowel Disease > Ibd
~45 spots leftby May 2026
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