IBD-Sleep: A Pilot Study Looking at Changes in Sleep Timing and IBD Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biopsy-proven IBD
Active IBD symptoms
Impaired IBD quality of life
Age >/=18 years old
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Morning light treatment
DeviceLight therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®.
Treatment-as-usual
BehavioralParticipants will not make modifications to their activities or sleep schedule.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Morning light treatmentExperimental treatment 1 intervention
Group B: Treatment-as-usualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 days2
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 days3
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 days4
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.
Time frame
Baseline, post-treatment approximately 36 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov