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

Early Phase 1

• Conditions: Obstructive Sleep Apnea; Pediatric Sleep Apnea
• Interventions: Diagnostic Test: INVOS

• Registration Number: NCT04321083
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Study Timeline

• Study Start: 2019-09-11
• Status Verified: 2020-03
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-24
• Last Update Submitted: 2020-03-24
• Study First Posted: 2020-03-25
• Last Update Posted: 2020-03-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 4-16 y/o pediatric population referred for PSG in Dana Hospital

Exclusion Criteria

• down synd.
• craniofacial malformation
• PPD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
O2 brain (central) measurement	INVOS	INVOS will be applied simultaneously for monitoring along with the regular polysomnography (sleep lab) workup

Primary Outcome Measures

Name	Time	Method
correlation between brain o2 levels to peripheral measurements	procedure (during the examination PGS)	correlation between brain o2 levels to peripheral measurements

Trial Locations

Locations (1)

Dana Duek pediatric hospital TASMC; 🇮🇱 Tel Aviv, Israel