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

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04321083
Acronym
O2SLEEP
Enrollment
100
Registered
2020-03-25
Start date
2019-09-11
Completion date
2022-12-31
Last updated
2020-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Pediatric Sleep Apnea

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.

Interventions

DIAGNOSTIC_TESTINVOS

INVOS monitoring brain o2 saturation

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

INVOS Medtronic device will be applied simultaneously with sleep lab monitoring

Eligibility

Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* down synd. * craniofacial malformation * PPD

Design outcomes

Primary

MeasureTime frameDescription
correlation between brain o2 levels to peripheral measurementsprocedure (during the examination PGS)correlation between brain o2 levels to peripheral measurements

Countries

Israel

Contacts

Primary ContactAri DeRowe, prof
arid@tlvmc.gov.il05246266357

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026