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Completed

NCT Number: NCT06094608

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morning light treatment

Device

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®

Treatment-as-usual

Behavioral

Participants will not make modifications to their activities or sleep schedule.

Primary outcomes

  1. 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

  1. Change in Patient Health Questionnaire 9 (PHQ-9) score

    Time frame: 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.

  2. Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS) Short-Form 8b

    Time frame: 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.

  3. For patients with Crohn's Disease (CD) - Change in Harvey Bradshaw Index (HBI)

    Time frame: 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.

  4. For patients with Ulcerative Colitis (UC) - Change in Simple Clinical Colitis Activity Index (SCCAI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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