Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea
NCT ID: NCT04321083
Last Updated: 2020-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
100 participants
INTERVENTIONAL
2019-09-11
2022-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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O2 brain (central) measurement
INVOS will be applied simultaneously for monitoring along with the regular polysomnography (sleep lab) workup
INVOS
INVOS monitoring brain o2 saturation
Interventions
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INVOS
INVOS monitoring brain o2 saturation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* craniofacial malformation
* PPD
4 Years
16 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Ari Derowe, prof
Role: PRINCIPAL_INVESTIGATOR
Dana Duek pediatric hospital, TASMC, TA, ISRAEL
Locations
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Dana Duek pediatric hospital TASMC
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TASMC18AD078918CTIL
Identifier Type: -
Identifier Source: org_study_id
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