Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea (O2SLEEP)

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Early Phase 1

Conditions: Obstructive Sleep Apnea; Pediatric Sleep Apnea

Treatments: Diagnostic Test: INVOS

Study type: Interventional

Funder types: Other

Identifiers

NCT04321083

TASMC18AD078918CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• down synd.
• craniofacial malformation
• PPD

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

O2 brain (central) measurement

Experimental group

Description:

INVOS will be applied simultaneously for monitoring along with the regular polysomnography (sleep lab) workup

Treatment:

Diagnostic Test: INVOS