Sleep Disorders in Pediatric Dialysis

This study has been completed.
Information provided by (Responsible Party):
Reshma Amin, The Hospital for Sick Children Identifier:
First received: August 15, 2012
Last updated: May 20, 2015
Last verified: May 2015
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.

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:

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.

Enrollment: 19
Study Start Date: August 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)


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.

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
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Please refer to this study by its identifier: NCT01667588

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Reshma Amin, MD The Hospital for Sick Children
  More Information

Responsible Party: Reshma Amin, Staff Respirologist, The Hospital for Sick Children Identifier: NCT01667588     History of Changes
Other Study ID Numbers: 1000031590 
Study First Received: August 15, 2012
Last Updated: May 20, 2015
Health Authority: Canada: Research Ethics Board

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Mental Disorders
Nervous System Diseases
Renal Insufficiency
Sleep Wake Disorders
Urologic Diseases processed this record on May 30, 2016