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

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06094608

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease	Device: Morning light treatment Behavioral: Treatment-as-usual	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Morning light treatment 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.	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®. Other Names: Re-Timer®
Active Comparator: Treatment-as-usual Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks.	Behavioral: Treatment-as-usual Participants will not make modifications to their activities or sleep schedule.

Arm

Intervention/Treatment

Experimental: Morning light treatment

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.

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®.

Other Names:

Re-Timer®

Active Comparator: Treatment-as-usual

Participants will be instructed to continue to follow their usual sleep schedule for 4 weeks.

Behavioral: Treatment-as-usual

Participants will not make modifications to their activities or sleep schedule.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48105

Sponsors and Collaborators

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

Investigators

Principal Investigator: Helen Burgess, Ph.D., University of Michigan
Principal Investigator: Cathy Goldstein, M.D., M.S., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Helen Burgess, Professor of Psychiatry, University of Michigan

ClinicalTrials.gov Identifier:

NCT06094608

Other Study ID Numbers:

HUM00234262
1R01DK136520

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Crohn Disease

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Oct 23, 2023