Sleep Disorders in Pediatric Dialysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01667588

Enrollment

Registered

2012-08-17

Start date

2012-08-31

Completion date

2014-03-31

Last updated

2015-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease (CKD)

Keywords

Chronic Kidney Disease (CKD), Pediatrics, Sleep Disorders

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of Sleep Disorders	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

Measure	Time frame	Description
Quality of Life	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.

Countries

Canada

Outcome results