OSANCT03933046
The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
A study testing PSG in people with OSA and Proteinuria, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- OSA, Proteinuria, Periodic Limb Movement Sleep Disorder
- What is being tested?
- PSG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age: 2-17 years
- Referred to overnight PSG due to suspected OSA or PLMD
- referred for evaluation in the nephrology clinic due to proteinuria
Who cannot join
- Known renal disease;
- diabetes mellitus;
- current use of ACE inhibitors or angiotensin receptor blockers;
- neuromuscular disorders
- craniofacial abnormalities
- syndromic conditions.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- OSA, Proteinuria, Periodic Limb Movement Sleep Disorder
- Being tested
- PSG
- Keywords
- osa, proteinuria, periodic limb movement disorder, children
- Medical subject headings
- Proteinuria, Sleep Apnea, Obstructive, Nocturnal Myoclonus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSGDiagnostic test
Also called urine analysis
polysomnography and urine analaysis for protein levels
| Study group | Role | What they receive |
|---|---|---|
| children referred to PSG due to suspected SDB | Experimental | Not described Receives: Diagnostic Test: PSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
morning urine protein/creatinine >0.2
Measured: 1 year
reported sleep duration (hours)
Measured: 1 year
morning urine protein/creatinine >0.2 post treatment of OSA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 May 2019 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933046
- Sponsor's protocol ID
- 0134-19-TLV
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
- ClinicalTrials.gov ID
- NCT03933046
- Acronym / sponsor ID
- 0134-19-TLV
- Conditions
- OSA, Proteinuria, Periodic Limb Movement Sleep Disorder
- Keywords
- osa, proteinuria, periodic limb movement disorder, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children referred to PSG due to suspected SDB | Experimental | Diagnostic Test: PSG |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age: 2-17 years
- Referred to overnight PSG due to suspected OSA or PLMD
- referred for evaluation in the nephrology clinic due to proteinuria
Key exclusion criteria (6 listed)
- Known renal disease;
- diabetes mellitus;
- current use of ACE inhibitors or angiotensin receptor blockers;
- neuromuscular disorders
- craniofacial abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSGAlso: urine analysispolysomnography and urine analaysis for protein levels | Diagnostic test | children referred to PSG due to suspected SDB |
Primary outcome
morning urine protein/creatinine >0.2
Time frame: 1 year
reported sleep duration (hours)
Time frame: 1 year
morning urine protein/creatinine >0.2 post treatment of OSA
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PSG in people with OSA and Proteinuria, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morning urine protein/creatinine >0.2 (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.