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The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children

NCT03933046 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-05-01

No results posted yet for this study

Summary

The presence of protein in urine is a common laboratory finding in children. Although proteinuria is usually benign, it can be a marker of a serious underlying renal disease or systemic disorder. Microalbuminuria can be one of the first subclinical manifestations of endothelial dysfunction and is associated with low grade systemic inflammation. Multiple studies from the adult population suggest that microalbuminuria above the upper quartile is linked with increased risk of coronary heart disease and death even after adjustment for the presence of diabetes mellitus, obesity and hypertension.

Obstructive sleep apnea (OSA) has been recognized as an independent risk factor for cardiovascular morbidity related to sympathetic nervous system overflow, metabolic dysregulation, inflammation and endothelial dysfunction secondary to repetitive hypoxia -reoxygenation events.

Therefore, there is a need for further studies to investigate the association between OSA and microalbuminuria in children. Furthermore, no studies have thus far investigated the association between other sleep disorders such as periodic limb movement (PLMD) and microalbuminuria in children.

Our hypothesis is that children with sleep disorders or short sleep duration have increased risk of proteinuria/microalbuminuria and that treatment and resolution of the sleep problem will be followed by improvement in proteinuria levels.

Conditions

  • OSA
  • Proteinuria
  • Periodic Limb Movement Sleep Disorder

Interventions

DIAGNOSTIC_TEST

PSG

polysomnography and urine analaysis for protein levels

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-05-01
Completion
2021-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933046 on ClinicalTrials.gov