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Sleep Disorders in Pediatric Dialysis

This study is not yet open for participant recruitment.
Verified August 2012 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01667588
First received: August 15, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition
Chronic Kidney Disease (CKD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Disorders in Pediatric Dialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Prevalence of Sleep Disorders [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Pediatric Quality of Life Inventory (Peds QL) generic core (version 4.0) scale is a 23-item multidimensional instrument for measuring pediatric HRQL.


Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pre-Dialysis
Dialysis

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The two study cohorts will be age and sex matched and constructed as follows:

  1. Pre-dialysis: Stage 4 CKD with an estimated GFR of 15-30 ml/min/1.73m2 based on IDMS Schwartz GFR
  2. 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.
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667588

Contacts
Contact: Reshma Amin, MD (416)813-6346

Locations
Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Reshma Amin, MD     (416)813-6346     reshma.amin@sickkids.ca    
Principal Investigator: Reshma Amin, MD            
Sub-Investigator: Elizabeth Harvey, MD            
Sub-Investigator: Indra Narang, MD            
Sub-Investigator: Khamisa Al-Mokali, MD            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Reshma Amin, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01667588     History of Changes
Other Study ID Numbers: 1000031590
Study First Received: August 15, 2012
Last Updated: August 15, 2012
Health Authority: Canada: Research Ethics Board

Keywords provided by The Hospital for Sick Children:
Chronic Kidney Disease (CKD)
Pediatrics
Sleep Disorders

Additional relevant MeSH terms:
Kidney Diseases
Sleep Disorders
Parasomnias
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
 Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013