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

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ClinicalTrials.gov Identifier: NCT02970149
Recruitment Status : Unknown
Verified February 2017 by University of Manitoba.
Recruitment status was:  Recruiting
First Posted : November 21, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

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.


Condition or disease Intervention/treatment
IBD Other: NA (observational)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying a Sleep Screener for Disease Relapse in Children With Inflammatory Bowel Disease
Study Start Date : November 2016
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 1, 2018



Primary Outcome Measures :
  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 [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Correlation between sleep disturbance scores and clinical disease activity indices (PCDAI and PUCAI), after controlling for symptoms of anxiety and depression [ Time Frame: 18 months ]
  2. Identification of which sleep component such as sleep duration and sleep latency is the best at detecting a disease relapse [ Time Frame: 18 months ]
  3. Identification of whether sleep disturbance more accurately predicts relapse for CD than for UC, after controlling for symptoms of anxiety and depression. [ Time Frame: 18 months ]


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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with IBD
Criteria

Inclusion Criteria

.1. Children aged 8 -17 years under the care of the Pediatric IBD Program at the Children's Hospital, Winnipeg and with an established diagnosis of IBD according to the North American Society of Pediatric Gastroenterology (NASPGHAN) Exclusion Criteria

  1. Children with IBD and known cognitive dysfunction or global developmental delay
  2. Children with IBD and concurrent gastrointestinal infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970149


Contacts
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Contact: WAEL EL-MATARY, MD, MSc 2047871039 WELMATARY@HSC.MB.CA
Contact: Vini Deora, MSc 2047874956 vdeora@exchange.hsc.mb.ca

Locations
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Canada, Manitoba
Children's Hospital Recruiting
Winnipeg, Manitoba, Canada, R3A 1S1
Contact: WAEL EL-MATARY, MD,MSc    2047871039    welmatary@HSC.MB.CA   
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: WAEL EL-MATARY, MD,MSc University of Manitoba

Publications of Results:
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02970149     History of Changes
Other Study ID Numbers: HS20099
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis