Sleep Disorders in Pediatric Dialysis
Recruitment status was Not yet recruiting
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Sleep Disorders in Pediatric Dialysis|
- 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.
- 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.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667588
|Contact: Reshma Amin, MD||(416)813-6346|
|The Hospital for Sick Children||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Reshma Amin, MD (416)813-6346 firstname.lastname@example.org|
|Principal Investigator: Reshma Amin, MD|
|Sub-Investigator: Elizabeth Harvey, MD|
|Sub-Investigator: Indra Narang, MD|
|Sub-Investigator: Khamisa Al-Mokali, MD|
|Principal Investigator:||Reshma Amin, MD||The Hospital for Sick Children|