IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan
- Study ID
- NCT06094608
- Status
- Recruiting
Conditions
- Crohn Disease
- Inflammatory Bowel Diseases
- Ulcerative Colitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Morning light treatment — DEVICELight therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®.
- Treatment-as-usual — BEHAVIORALParticipants will not make modifications to their activities or sleep schedule.
Study Details
This research study is testing whether changes in sleep timing and morning light treatment may have an impact on symptoms related to inflammatory bowel disease.
Key Dates
- Start date
- Feb 1, 2024
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 68 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Morning light treatmentA 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.
- Active Comparator: Treatment-as-usualParticipants will be instructed to continue to follow their usual sleep schedule for 4 weeks.
Primary Outcome Measure
Change in Short IBD Questionnaire (SIBDQ) score [ Time Frame: Baseline, post-treatment approximately 36 days ]
Central Contacts
- Helen Burgess734-615-8303
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48105 |
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