Measurement of Cerebral rSO2 Levels During Sleep in Child... | NCT04321083

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

NCT04321083

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Mar 25, 2020Actual

Enrollment

100Estimated

Phase

Early Phase 1

Conditions

Obstructive Sleep Apnea
Pediatric Sleep Apnea

Interventions

INVOS

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2019Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 24, 2020

First Posted Date

Mar 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2020

Last Update Posted Date

Mar 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Yes

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
O2 brain (central) measurement	Experimental	INVOS will be applied simultaneously for monitoring along with the regular polysomnography (sleep lab) workup	Diagnostic Test: INVOS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INVOS	Diagnostic Test	INVOS monitoring brain o2 saturation	O2 brain (central) measurement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation between brain o2 levels to peripheral measurements	correlation between brain o2 levels to peripheral measurements	procedure (during the examination PGS)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

down synd.
craniofacial malformation
PPD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ari DeRowe, prof	Contact	05246266357		arid@tlvmc.gov.il

Overall Officials

Name	Affiliation	Role
Ari Derowe, prof	Dana Duek pediatric hospital, TASMC, TA, ISRAEL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana Duek pediatric hospital TASMC	Recruiting	Tel Aviv			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided