Status:
RECRUITING
IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Inflammatory Bowel Diseases
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
This study will test a consumer health light therapy device (Re-Timer) for people with inflammatory bowel disease to better understand how it affects IBD-related quality of life.
Eligibility Criteria
Inclusion
- Biopsy-proven IBD
- Active IBD symptoms
- Impaired IBD quality of life
- Age \>/=18 years old
- Fluency in English
- Physically able to travel for study visits
Exclusion
- Ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses, are planned for imminent surgery and/or have short bowel syndrome
- Other significant chronic disease
- Retinal pathology, history of eye surgery, taking photosensitizing medications
- Recent history of light treatment
- Lifetime psychotic or bipolar disorder
- Acute suicidal ideation
- Substance use disorder in the past 3 months, cannabis use \>1/week
- High risk for or diagnosed with obstructive sleep apnea, and/or narcolepsy
- Severe hearing problem, intellectual disability or serious cognitive impairment
- Pregnant, trying to get pregnant, or breastfeeding
- Night work or travel outside the eastern time zone in the past month
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06094608
Start Date
February 1 2024
End Date
May 31 2026
Last Update
April 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan
Ann Arbor, Michigan, United States, 48105