IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
2 other identifiers
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
April 27, 2026
April 1, 2026
3.4 years
October 16, 2023
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Short IBD Questionnaire (SIBDQ) score
SIBDQ is 10 questions, each with a Likert like scale with 7 options and lower scores indicate poorer quality of life.
Baseline, post-treatment approximately 36 days
Secondary Outcomes (4)
Change in Patient Health Questionnaire 9 (PHQ-9) score
Baseline, post-treatment approximately 36 days
Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS) Short-Form 8b
Baseline, post-treatment approximately 36 days
For patients with Crohn's Disease (CD) - Change in Harvey Bradshaw Index (HBI)
Baseline, post-treatment approximately 36 days
For patients with Ulcerative Colitis (UC) - Change in Simple Clinical Colitis Activity Index (SCCAI)
Baseline, post-treatment approximately 36 days
Study Arms (2)
Morning light treatment
EXPERIMENTALA 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.
Treatment-as-usual
ACTIVE COMPARATORParticipants will be instructed to continue to follow their usual sleep schedule for 4 weeks.
Interventions
Light therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®.
Participants will not make modifications to their activities or sleep schedule.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48105, United States
Related Publications (1)
Cohen-Mekelburg S, Goldstein CA, Rizvydeen M, Fayyaz Z, Patel PJ, Berinstein JA, Bishu S, Cushing-Damm KC, Kim HM, Burgess HJ. Morning light treatment for inflammatory bowel disease: a clinical trial. BMC Gastroenterol. 2024 May 22;24(1):179. doi: 10.1186/s12876-024-03263-2.
PMID: 38778264DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Burgess, Ph.D.
University of Michigan
- PRINCIPAL INVESTIGATOR
Cathy Goldstein, M.D., M.S.
University of Michigan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessor will be blinded to study arm. The PI, study coordinator and research assistants will remain unblinded to perform safety assessments and provide feedback on intervention adherence. Blinded staff will wear buttons as an upfront visual cue to remind participants not to talk about their treatment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
October 16, 2023
First Posted
October 23, 2023
Study Start
February 1, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
- Access Criteria
- Researchers requesting data will first have to sign a data sharing agreement, agreeing to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, electronically securing the data while in use, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, no use of the data for commercial purposes and proper acknowledgement of the data resource.
The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.