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

University of Michigan

Status: Enrolling

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Behavioral: Treatment-as-usual; Device: Morning light treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06094608

1R01DK136520 (U.S. NIH Grant/Contract)

HUM00234262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Morning light treatment

Experimental group

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.

Treatment:

Device: Morning light treatment

Treatment-as-usual

Active Comparator group

Description:

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

Treatment:

Behavioral: Treatment-as-usual