Crohn Disease, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
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.
Interventions
DEVICEMorning light treatment
Light therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®.
BEHAVIORALTreatment-as-usual
Participants will not make modifications to their activities or sleep schedule.
Sponsors
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will be blinded to study arm. The PI, study coordinator and research assistants will remain unblinded to perform safety assessments and provide feedback on intervention adherence. Blinded staff will wear buttons as an upfront visual cue to remind participants not to talk about their treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHelen Burgess, Ph.D.
University of Michigan
PRINCIPAL_INVESTIGATORCathy Goldstein, M.D., M.S.
University of Michigan
Outcome results
None listed