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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094608
• Other study ID #: HUM00234262
• Secondary ID: 1R01DK136520
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Muneer Rizvydeen
• Phone: Phone 734-232-9281
• Email: ibd-sleep[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Device:
• Morning light treatment
Light therapy via the Re-Timer. Participants will conduct light treatment in the mornings at home for one hour using Re-timer®.

Behavioral:
• Treatment-as-usual
Participants will not make modifications to their activities or sleep schedule.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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