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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Device: Morning light treatment; Behavioral: Treatment-as-usual

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 Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Burgess; Phone Number: 734-615-8303; Email: bhelen@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • University of Michigan
      • Contact: Helen Burgess, Ph.D.; Phone Number: 734-615-8303; Email: bhelen@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morning light treatment; A 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.	Device: Morning light treatment; Light therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®.; Other Names: Re-Timer®
Active Comparator: Treatment-as-usual; Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks.	Behavioral: Treatment-as-usual; Participants will not make modifications to their activities or sleep schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire 9 (PHQ-9) score	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.	Baseline, post-treatment approximately 36 days
Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS) Short-Form 8b	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.	Baseline, post-treatment approximately 36 days
For patients with Crohn's Disease (CD) - Change in Harvey Bradshaw Index (HBI)	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.	Baseline, post-treatment approximately 36 days
For patients with Ulcerative Colitis (UC) - Change in Simple Clinical Colitis Activity Index (SCCAI)	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.	Baseline, post-treatment approximately 36 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Helen Burgess, Ph.D., University of Michigan; Principal Investigator: Cathy Goldstein, M.D., M.S., University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: HUM00234262; 1R01DK136520 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
• IPD Sharing Time Frame: After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No