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

NCT03933046 | Unknown

• 1 other identifier: 0134-19-TLV
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

osa; proteinuria; periodic limb movement disorder; children

Outcome Measures

Primary Outcomes (3)

• morning urine protein/creatinine >0.2

  1 year

• reported sleep duration (hours)

  1 year

• morning urine protein/creatinine >0.2 post treatment of OSA

  1 year

Study Arms (1)

children referred to PSG due to suspected SDB

EXPERIMENTAL

Diagnostic Test: PSG

Interventions

PSG DIAGNOSTIC_TEST

polysomnography and urine analaysis for protein levels

Also known as: urine analysis

children referred to PSG due to suspected SDB

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age: 2-17 years
• Referred to overnight PSG due to suspected OSA or PLMD
• referred for evaluation in the nephrology clinic due to proteinuria

You may not qualify if:

• Known renal disease;
• diabetes mellitus;
• current use of ACE inhibitors or angiotensin receptor blockers;
• neuromuscular disorders
• craniofacial abnormalities
• syndromic conditions.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Proteinuria; Sleep Apnea, Obstructive; Nocturnal Myoclonus Syndrome

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Parasomnias

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: May 1, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 1, 2019

Record last verified: 2019-04