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

Last updated: March 24, 2020
Sponsor: Tel-Aviv Sourasky Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Sleep Apnea Syndromes

Sleep Disorders (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04321083
TASMC18AD078918CTIL
  • Ages 4-16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • down synd.

  • craniofacial malformation

  • PPD

Study Design

Total Participants: 100
Study Start date:
September 11, 2019
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Dana Duek pediatric hospital TASMC

    Tel Aviv,
    Israel

    Active - Recruiting

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