Back to resultsIBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
Primary Purpose
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morning light treatment
Treatment-as-usual
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Morning light treatment
Treatment-as-usual
Arm Description
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.
Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT06094608
First Posted
October 16, 2023
Last Updated
October 16, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT06094608
Brief Title
IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
Official Title
IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morning light treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment-as-usual
Arm Type
Active Comparator
Arm Description
Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Morning light treatment
Other Intervention Name(s)
Re-Timer®
Intervention Description
Light therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®.
Intervention Type
Behavioral
Intervention Name(s)
Treatment-as-usual
Intervention Description
Participants will not make modifications to their activities or sleep schedule.
Primary Outcome Measure Information:
Title
Change in Short IBD Questionnaire (SIBDQ) score
Description
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 Outcome Measure Information:
Title
Change in Patient Health Questionnaire 9 (PHQ-9) score
Description
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
Title
Change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance (PROMIS) Short-Form 8b
Description
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
Title
For patients with Crohn's Disease (CD) - Change in Harvey Bradshaw Index (HBI)
Description
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
Title
For patients with Ulcerative Colitis (UC) - Change in Simple Clinical Colitis Activity Index (SCCAI)
Description
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.
Time Frame
Baseline, post-treatment approximately 36 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muneer Rizvydeen
Phone
Phone 734-232-9281
Email
ibd-sleep@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Burgess, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cathy Goldstein, M.D., M.S.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Burgess, Ph.D.
Phone
734-615-8303
Email
bhelen@umich.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
IPD Sharing Time Frame
After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
IPD Sharing Access Criteria
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.
Learn more about this trial
IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
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