The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children identifier recruitment status First Posted Last update posted
NCT03933046 Not yet recruiting May 1, 2019 May 1, 2019

study description
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.

Condition or Disease: OSA
Periodic Limb Movement Sleep Disorder
Intervention/treatment: Diagnostic Test: PSG
Phase: N/A
Detailed Description

200 children aged 2-18 years that will be referred to the Sleep Disorders Center for
overnight polysomnography due to suspected sleep disordered breathing or PLMD will be
recruited to the study during their first visit in the sleep clinic. During that study, an
informed consent will be completed by the parents. Data on weekdays and weekends sleep
duration as well as personal and family history of kidney disease will be collected.

Exclusion criteria:1. Known renal disease; 2. diabetes mellitus; 3. current use of ACE
inhibitors or angiotensin receptor blockers; 4. neuromuscular disorders or craniofacial
abnormalities; 5. syndromic conditions.

All participants will undergo physical examination. Weight and height will be measured, and
body mass index (BMI) z-score will be calculated.

Blood pressure will be measured on the first visit in the sleep clinic by a trained physician
as specified in recent guidelines. 19

Overnight polysomnography will be carried out in the Sleep Disorders Laboratory and the
following signals will be recorded: electroencephalogram (EEG; C3/M2, C2/M1, O1/M2, O2/M1);
right and left oculogram; submental and tibial electromyogram; body position;
electrocardiogram; thoracic and abdominal wall motion; oronasal airflow (three-pronged
thermistor and nasal pressure transducer); and oxygen saturation of hemoglobin (SpO2).
Arousals, sleep stages and respiratory events will be scored, and polysomnography indices
will be defined according to the recent American Academy of Sleep Medicine recommendations .

First void urine samples will be collected in a sterile cup the morning following the
polysomnography (6:00-7:00 am). For each sample urinalysis, protein/creatinine and
albumin/creatinine will be measured. Urinary albumin and protein excretion will be the
primary outcome measure. Proteinuria will be defined as protein/creatinine greater than 0.2
and albuminuria will be defined as albumin/creatinine above age-adjusted limits Children who
will be diagnosed with moderate-severe OSA will be referred to an ENT surgeon for
adenotonsillectomy, the first line of treatment in pediatric OSA. Six to 10 weeks following
surgery, these children will be requested to undergo additional PSG evaluation. First void
urine samples will be collected the following morning.

In addition- 100 children referred to the pediatric nephrology clinic due to asymptomatic
albuminuria/proteinuria will be recruited. Parents will be required to complete a designated
sleep questionnaire that includes items on sleep duration, SDB and RLS symptoms. Exclusion
criteria, as described above for the entire cohort, will also apply to this subpopulation.

Informed consent will be completed by the parents.

study design
Study Type: Interventional
Estimated Enrollment : 300 participants
Intervention Model : Single Group Assignment
Masking: None (Open Label) ()
Primary Purpose: Screening
Official Title: The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
Estimated Study Start Date: May 2019
Estimated Primary Completion Date: May 2021
Estimated Study Completion Date: September 2021

Arms and interventions
Arm Intervention/treatment
Experimental: children referred to PSG due to suspected SDB
Diagnostic Test: PSG
polysomnography and urine analaysis for protein levels
outcome measures
Primary Outcome Measures: 1. morning urine protein/creatinine >0.2 [ Time Frame: 1 year ]
2. reported sleep duration (hours) [ Time Frame: 1 year ]
3. morning urine protein/creatinine >0.2 post treatment of OSA [ Time Frame: 1 year ]

Eligibility Criteria
Ages Eligible for Study: 2 to 17 Years (Child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. age: 2-17 years

2. Referred to overnight PSG due to suspected OSA or PLMD

3. referred for evaluation in the nephrology clinic due to proteinuria

Exclusion Criteria:

1. Known renal disease;

2. diabetes mellitus;

3. current use of ACE inhibitors or angiotensin receptor blockers;

4. neuromuscular disorders

5. craniofacial abnormalities

6. syndromic conditions.

Contacts and Locations
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
More Information
Responsible Party : Tel-Aviv Sourasky Medical Center Identifier : NCT03933046     
Other Study ID Numbers : 0134-19-TLV
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Last Verified : April 2019
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tel-Aviv Sourasky Medical Center: periodic limb movement disorder
Additional relevant MeSH terms :
Sleep Wake Disorders