Identifying a Sleep Screener for Disease Relapse in Children With Inflammatory Bowel Disease

NCT02970149 | Unknown

• 1 other identifier: HS20099
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Inflammatory bowel disease (IBD) is a group of disorders characterized by chronic inflammation of the gastrointestinal tract with remissions and relapses. The two most common subtypes are Crohn's disease (CD) and ulcerative colitis (UC). In 2012, the burden-of-illness report from the Crohn's and Colitis Canada estimated that the direct medical costs of IBD in Canada were over one billion dollars, primarily funded through the Canadian public healthcare system. Many life style-related factors may play an important role in the pathogenesis of IBD and can contribute to trigger disease relapse, but several of these factors are poorly understood. These factors may include sleep disturbances. Data on sleep disturbance in children with IBD are limited. Sleep deprivation has been shown to cause reactivation of colitis in animal studies but similar data are lacking in humans especially in children. Hypothesis: In children with IBD, high scores for a sleep disturbance screener will be positively associated with IBD relapse Objective: To develop a non-invasive non-costly tool to screen for relapses in pediatric IBD patients through examining the association between sleep disturbances and disease relapse in children with IBD Methods: This study will incorporate an observational prospective design. Participants: Participants will be 90 children (ages 8-17 years ) under the care of the Pediatric IBD Program at the Children's Hospital, Winnipeg. All participants will have an established diagnosis of IBD. Measures: Sleep disturbances will be assessed using a sleep diary. Patients will be asked complete a daily sleep diary in the week preceding their clinic appointment. The sleep diary will provide information about latency to fall asleep, number of awakenings, duration of awakenings, total sleep time, sleep quality, and sleep efficiency. Mucosal inflammation will be assessed by measuring fecal calprotectin and clinical disease activity will be measured Pediatric Crohn's disease activity index (PCDAI) for CD and pediatric ulcerative colitis activity index (PUCAI) for UC at clinic visits Anxiety/Depression: As anxiety and depression are often comorbid with disturbed sleep, levels of symptoms in both domains will be assessed at clinic visit using the Child and Parent Report Versions of the Spence Anxiety Scale and the Child Depression Inventory (v. 2). Procedure: Upon obtaining informed consent, each participant will complete 7 days of sleep diary recording in the week prior to their clinic appointment. During the clinic visit, the PCDAI or PUCAI, Spence Anxiety Scales, Child Depression Inventory will be completed. Fecal samples will be collected for fecal calprotectin measurement as a surrogate marker for mucosal inflammation. Other investigations will include blood samples for serum hemoglobin, serum albumin, and inflammatory markers. Stool samples for infection screen will also be collected to exclude any possibility for gastrointestinal infection on top of IBD.A second clinic visit will be scheduled 3 months later and the whole process will be repeated in the second visit. Regression analysis will be performed to examine the association between sleep disturbances and disease activity, characteristics and patients' demographics Outcomes: Primary outcome: Cut-off score of a sleep screener that is associated with disease relapse (as diagnosed by fecal calprotectin value of \>100 microgram/gram of stools) in children with IBD Secondary outcomes: 1. Correlation between sleep disturbance scores and clinical disease activity indices (PCDAI and PUCAI). 2. Identification of which sleep component (sleep duration, latency, fatigue, subjective quality) is the best at detecting a disease relapse. 3.Identification of whether sleep disturbance more accurately predicts relapse for CD than for UC.

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

• Cut-off score of a sleep screener in relation to disease relapse (as diagnosed by fecal calprotectin value of >100 microgram/gram of stools) in children with IBD

  18 months

Secondary Outcomes (3)

• Correlation between sleep disturbance scores and clinical disease activity indices (PCDAI and PUCAI), after controlling for symptoms of anxiety and depression

  18 months

• Identification of which sleep component such as sleep duration and sleep latency is the best at detecting a disease relapse

  18 months

• Identification of whether sleep disturbance more accurately predicts relapse for CD than for UC, after controlling for symptoms of anxiety and depression.

  18 months

Interventions

NA (observational) OTHER

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with IBD

You may not qualify if:

• Children with IBD and known cognitive dysfunction or global developmental delay
• Children with IBD and concurrent gastrointestinal infection

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Children's Hospital

Winnipeg, Manitoba, R3A 1S1, Canada

RECRUITING

Related Publications (1)

• Meltzer LJ, Biggs S, Reynolds A, Avis KT, Crabtree VM, Bevans KB. The Children's Report of Sleep Patterns--Sleepiness Scale: a self-report measure for school-aged children. Sleep Med. 2012 Apr;13(4):385-9. doi: 10.1016/j.sleep.2011.12.004. Epub 2012 Feb 10.

  PMID: 22326832 RESULT

MeSH Terms

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• WAEL EL-MATARY, MD,MSc

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WAEL EL-MATARY, MD, MSc

CONTACT

2047871039; WELMATARY@HSC.MB.CA

Vini Deora, MSc

CONTACT

2047874956; vdeora@exchange.hsc.mb.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)