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

Not Applicable

Recruiting

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Ulcerative Colitis

• Registration Number: NCT06094608
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Study Start: 2024-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Short IBD Questionnaire (SIBDQ) score	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 Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS) Short-Form 8b	Baseline, post-treatment approximately 36 days	PROMIS Sleep Disturbance measures self-reported sleep quality during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance.
For patients with Crohn's Disease (CD) - Change in Harvey Bradshaw Index (HBI)	Baseline, post-treatment approximately 36 days	The HBI is a clinician-rated measure of disease severity in Crohn's disease (CD). The HBI has items addressing a range of symptoms including general well-being, abdominal pain, liquidity/softness of stool, presence of an abdominal mass and complications. The total score reflects the following: score \<5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and \>16 = severe disease activity.
For patients with Ulcerative Colitis (UC) - Change in Simple Clinical Colitis Activity Index (SCCAI)	Baseline, post-treatment approximately 36 days	The SCCAI is a clinician-rated measure of disease severity in ulcerative colitis (UC). The SCCAI has items addressing a range of symptoms from bowel frequency, defecation urgency, blood in stool, general well-being, and other extracolonic disease features. Scores range from 0 to 19 points, and scores \< or equal to 2.5 indicate clinical remission.
Change in Patient Health Questionnaire 9 (PHQ-9) score	Baseline, post-treatment approximately 36 days	PHQ-9 is a depression score ranging from 0 through 27. No depression 0-4, mild 5-9, moderate 10-14, moderately severe 15-19, severe 20-27.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States