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NCT03933046
The Association Between Sleep Duration and Sleep Disorders and Proteinuria in Children
NA trial testing PSG in OSA in 300 participants. Status unknown.
1 May 2021
Quick facts
| Lead sponsor | Tel-Aviv Sourasky Medical Center |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 300 |
| Start date | 1 May 2019 |
| Primary completion | 1 May 2021 |
| Estimated completion | 1 September 2021 |
Drugs / interventions tested
- PSG
Conditions studied
- OSA — all drugs for OSA →
- Proteinuria — all drugs for Proteinuria →
- Periodic Limb Movement Sleep Disorder — all drugs for Periodic Limb Movement Sleep Disorder →
Sponsor
Tel-Aviv Sourasky Medical Center
Who can join
Adults 2 to 17, any sex, with OSA or Proteinuria. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03933046
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03933046 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center
- Last refreshed: 1 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03933046.
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