Sleep Disorders in Pediatric Dialysis

Chronic Kidney Disease (CKD) Clinical Trial

Official title:

Sleep Disorders in Pediatric Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667588
• Other study ID #: 1000031590
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: May 20, 2015
• Start date: August 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2015
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethics Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Parasomnias
• Renal Insufficiency, Chronic
• Sleep Disorders

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Sleep Disorders	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	No
Secondary	Quality of Life	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	No