The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
Primary Purpose
OSA, Proteinuria, Periodic Limb Movement Sleep Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PSG
Sponsored by
About this trial
This is an interventional screening trial for OSA focused on measuring osa, proteinuria, periodic limb movement disorder, children
Eligibility Criteria
Inclusion Criteria:
- age: 2-17 years
- Referred to overnight PSG due to suspected OSA or PLMD
- referred for evaluation in the nephrology clinic due to proteinuria
Exclusion Criteria:
- Known renal disease;
- diabetes mellitus;
- current use of ACE inhibitors or angiotensin receptor blockers;
- neuromuscular disorders
- craniofacial abnormalities
- syndromic conditions.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
children referred to PSG due to suspected SDB
Arm Description
Outcomes
Primary Outcome Measures
morning urine protein/creatinine >0.2
reported sleep duration (hours)
morning urine protein/creatinine >0.2 post treatment of OSA
Secondary Outcome Measures
Full Information
NCT ID
NCT03933046
First Posted
April 14, 2019
Last Updated
April 28, 2019
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03933046
Brief Title
The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
Official Title
The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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 . 20
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA, Proteinuria, Periodic Limb Movement Sleep Disorder
Keywords
osa, proteinuria, periodic limb movement disorder, children
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
children referred to PSG due to suspected SDB
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
PSG
Other Intervention Name(s)
urine analysis
Intervention Description
polysomnography and urine analaysis for protein levels
Primary Outcome Measure Information:
Title
morning urine protein/creatinine >0.2
Time Frame
1 year
Title
reported sleep duration (hours)
Time Frame
1 year
Title
morning urine protein/creatinine >0.2 post treatment of OSA
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age: 2-17 years
Referred to overnight PSG due to suspected OSA or PLMD
referred for evaluation in the nephrology clinic due to proteinuria
Exclusion Criteria:
Known renal disease;
diabetes mellitus;
current use of ACE inhibitors or angiotensin receptor blockers;
neuromuscular disorders
craniofacial abnormalities
syndromic conditions.
12. IPD Sharing Statement
Learn more about this trial
The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
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