- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01667588
Sleep Disorders in Pediatric Dialysis
May 20, 2015 updated by: Reshma Amin, The Hospital for Sick Children
Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with a reported prevalence of 60-80%.
To date three studies have reported on SDs in children with CKD but these have all been based on questionnaire data alone.
The findings were not confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a validated tool to assess the sleep/ wake cycle over a prolonged period in the home.
This is highly relevant given the poor sensitivity and specificity of even validated questionnaires alone.
The effect of untreated pediatric SD is pervasive.
This study will provide the first objective assessment of SDs using PSGs in children with severe CKD, both on and off dialysis.
Therefore, we will recognize and when possible treat SD in this severe CKD cohort potentially contributing to their immediate management (eg improved control of hypertension, improved school performance), while improving their Quality of Life (QOL) and helping ensure they achieve their full potential.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The two study cohorts will be age and sex matched and constructed as follows:
- Pre-dialysis: Stage 4 CKD with an estimated GFR of 15-30 ml/min/1.73m2 based on IDMS Schwartz GFR
- Dialysis: CKD receiving outpatient hemodialysis (HD) or peritoneal dialysis (PD) for a minimum of 1 month. The PSG will be completed after the longest inter-dialytic interval for HD patients. Patients on PD will undergo PSG while on their usual cycler nocturnal dialysis regimen.
Description
Inclusion Criteria:
- 0 to 18 years
- Caregivers must be able to read English
- Patients with either Stage 4 Chronic Kidney Disease (CKD) with an estimated GFR of 15-30 ml/min/1.73m2 based on IDMS Schwartz GFR OR patients with CKD receiving outpatient hemodialysis (HD) or peritoneal dialysis (PD) for a minimum of 1 month
- Informed consent
Exclusion Criteria:
- Caregivers cannot read English
- Informed consent not given
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pre-Dialysis
|
Dialysis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Sleep Disorders
Time Frame: Baseline
|
Report the prevalence of sleep disorders in a cohort of severe Chronic Kidney Disorder children both on and off dialysis based on PSG, actigraphy, and questionnaire.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: Baseline
|
The Pediatric Quality of Life Inventory (Peds QL) generic core (version 4.0) scale is a 23-item multidimensional instrument for measuring pediatric HRQL.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Reshma Amin, MD, The Hospital for Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
August 15, 2012
First Submitted That Met QC Criteria
August 15, 2012
First Posted (Estimate)
August 17, 2012
Study Record Updates
Last Update Posted (Estimate)
May 22, 2015
Last Update Submitted That Met QC Criteria
May 20, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000031590
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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