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NCT04321083 Clinical Trial

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

Obstructive Sleep Apnea Clinical Trial

— O2SLEEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04321083
Other study ID # TASMC18AD078918CTIL
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 11, 2019
Est. completion date December 31, 2022

Study information
Verified date March 2020
Source Tel-Aviv Sourasky Medical Center
Contact Ari DeRowe, prof
Phone 05246266357
Email arid@tlvmc.gov.il
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 4 Years to 16 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- down synd.

- craniofacial malformation

- PPD

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• INVOS
INVOS monitoring brain o2 saturation

Locations
Country Name City State
Israel Dana Duek pediatric hospital TASMC Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary correlation between brain o2 levels to peripheral measurements correlation between brain o2 levels to peripheral measurements procedure (during the examination PGS)
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