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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease

Intervention / Treatment
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* Device: Morning light treatment
* Behavioral: Treatment-as-usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven IBD Clinically active disease 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |