NCT04321083

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obstructive Sleep Apnea
• Pediatric Sleep Apnea

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	INVOS	INVOS monitoring brain o2 saturation

Timeline

• Start date: 2019-09-11
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-03-25
• Last updated: 2020-03-25

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study