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

University of Michigan64 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

Interventions

Morning light treatmentDEVICE

Light therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®.

Treatment-as-usualBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, post-treatment approximately 36 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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