Sleep Disorders in Pediatric Dialysis

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

August 15, 2012
August 15, 2012
August 2012
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Sleep Disorders in Pediatric Dialysis
Sleep Disorders in Pediatric Dialysis

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.
Chronic Kidney Disease (CKD)
Not Provided
  • Pre-Dialysis
  • Dialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
January 2014
August 2013   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact: Reshma Amin, MD (416)813-6346
Canada
 
NCT01667588
1000031590
No
The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Reshma Amin, MD The Hospital for Sick Children
The Hospital for Sick Children
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP