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Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea — O2SLEEP  

Obstructive Sleep Apnea Clinical Trial

Official title:
Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea

Clinical Trial Summary

The gold standard of obstructive sleep apnea (OSA) is (PSG)POLYSOMNOGRAPHY. During the examination, the patient is monitored by saturation, EEG and other measurements.

Near infrared spectroscopy is an uprising technology allowing non invasive measurement of the frontal lobe oxygenation. It is painless and does not have side effects. We believe that brain saturation will be more accurate then peripheral pulse oximeter and will be better correlated with the clinical presentation of OSA.

Clinical Trial Description

a prospective cohort study study group - pediatric population referred to PSG in Dana Duek Hospital. After informed consent received from the parents, the parents will fulfill "Connors" (age 6 +) & "Brief" (age 4-6) questionnaires.

During the PSG, the brain saturation will be monitored by INVOS(TM) Medtronic device. They will be monitored & synchronized with the peripheral saturation documented performed as part of the PSG examination.

The brain saturation & peripheral saturation levels will be compared and both will be correlated to the questionnaires & AHI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04321083
Study type Interventional
Source Tel-Aviv Sourasky Medical Center
Contact Ari DeRowe, prof
Phone 05246266357
Email arid@tlvmc.gov.il
Status Recruiting
Phase Early Phase 1
Start date September 11, 2019
Completion date December 31, 2022
View Details
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