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

Primary Purpose

Obstructive Sleep Apnea, Pediatric Sleep Apnea

Status
Unknown status
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
INVOS
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • down synd.
  • craniofacial malformation
  • PPD

Sites / Locations

  • Dana Duek pediatric hospital TASMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

O2 brain (central) measurement

Arm Description

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

Outcomes

Primary Outcome Measures

correlation between brain o2 levels to peripheral measurements
correlation between brain o2 levels to peripheral measurements

Secondary Outcome Measures

Full Information

First Posted
March 23, 2020
Last Updated
March 24, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04321083
Brief Title
Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea
Acronym
O2SLEEP
Official Title
Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Pediatric Postmarket Surveillance of a Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Pediatric Sleep Apnea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
INVOS Medtronic device will be applied simultaneously with sleep lab monitoring
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
O2 brain (central) measurement
Arm Type
Experimental
Arm Description
INVOS will be applied simultaneously for monitoring along with the regular polysomnography (sleep lab) workup
Intervention Type
Diagnostic Test
Intervention Name(s)
INVOS
Intervention Description
INVOS monitoring brain o2 saturation
Primary Outcome Measure Information:
Title
correlation between brain o2 levels to peripheral measurements
Description
correlation between brain o2 levels to peripheral measurements
Time Frame
procedure (during the examination PGS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 4-16 y/o pediatric population referred for PSG in Dana Hospital Exclusion Criteria: down synd. craniofacial malformation PPD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ari DeRowe, prof
Phone
05246266357
Email
arid@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Derowe, prof
Organizational Affiliation
Dana Duek pediatric hospital, TASMC, TA, ISRAEL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Duek pediatric hospital TASMC
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ari DeRowe, Prof
Phone
0524266357
Email
AriD@tlvmc.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

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

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