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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK136520 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning light treatment | Experimental | 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. |
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| Treatment-as-usual | Active Comparator | Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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®. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Burgess, Ph.D. | University of Michigan | Principal Investigator |
| Cathy Goldstein, M.D., M.S. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38778264 | Derived | 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. |
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The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
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.
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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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.
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| Treatment-as-usual | Behavioral | Participants will not make modifications to their activities or sleep schedule. |
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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 |
| D003092 | Colitis |
| D003108 | Colonic Diseases |