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Sleep Disorders in Pediatric Dialysis

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ClinicalTrials.gov Identifier: NCT01667588
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Reshma Amin, The Hospital for Sick Children

Brief Summary:
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 or disease
Chronic Kidney Disease (CKD)

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Disorders in Pediatric Dialysis
Study Start Date : August 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Pre-Dialysis
Dialysis



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): NCT01667588


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

Responsible Party: Reshma Amin, Staff Respirologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01667588     History of Changes
Other Study ID Numbers: 1000031590
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

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

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