NCT04321083

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2019

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

March 23, 2020

Last Update Submit

March 24, 2020

Conditions

Obstructive Sleep ApneaPediatric Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • correlation between brain o2 levels to peripheral measurements

    correlation between brain o2 levels to peripheral measurements

    procedure (during the examination PGS)

Study Arms (1)

O2 brain (central) measurement

EXPERIMENTAL

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

Diagnostic Test: INVOS

Interventions

INVOSDIAGNOSTIC_TEST

INVOS monitoring brain o2 saturation

O2 brain (central) measurement

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • down synd.
  • craniofacial malformation
  • PPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Duek pediatric hospital TASMC

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ari Derowe, prof

    Dana Duek pediatric hospital, TASMC, TA, ISRAEL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ari DeRowe, prof

CONTACT

05246266357arid@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: INVOS Medtronic device will be applied simultaneously with sleep lab monitoring
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR
Post-Marketing Study
Yes

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

September 11, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)