IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms

University of Michigan1 site in 1 country68 target enrollmentFebruary 1, 2024

ConditionsInflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammatory Bowel Diseases
Sponsor: University of Michigan
Enrollment: 68
Locations: 1
Primary Endpoint: Change in Short IBD Questionnaire (SIBDQ) score
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2024

End Date

May 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Helen Burgess

Professor of Psychiatry

University of Michigan

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

Outcomes

Primary Outcomes

Change in Short IBD Questionnaire (SIBDQ) score

Time Frame: Baseline, post-treatment approximately 36 days

SIBDQ is 10 questions, each with a Likert like scale with 7 options and lower scores indicate poorer quality of life.

Secondary Outcomes

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)
Change in Patient Health Questionnaire 9 (PHQ-9) score(Baseline, post-treatment approximately 36 days)