NCT06094608 IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
| NCT ID | NCT06094608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Inflammatory Bowel Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2024-02-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Helen Burgess, Ph.D.
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06094608 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06094608 currently recruiting?
Yes, NCT06094608 is actively recruiting participants. Contact the research team at bhelen@med.umich.edu for enrollment information.
Where is the NCT06094608 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06094608 clinical trial?
NCT06094608 is sponsored by University of Michigan. The principal investigator is Helen Burgess, Ph.D. at University of Michigan. The trial plans to enroll 68 participants.