Oximetry in Children for Sleep Apnea Diagnosis

December 29, 2022 updated by: Dr. Iulia IOAN, Central Hospital, Nancy, France

Oximetry for Diagnosis of Obstructive Sleep Apnea Syndrome in Children

Video-polygraphy or video-polysomnography (vP(S)G) is the reference exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children as it allows the detection of the respiratory events presented by the child during sleep. This exam requires a one-night hospitalization and several sensors installed on the child's body, sometimes not well-accepted in children. Portable oximetry is an easier test to perform, better accepted by the child, and gives the desaturation index that may be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify a moderate-severe OSAS in children.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Video-polysomnography (vPSG) with video surveillance and monitoring by a nurse to reposition the sensors if needed during the night is the gold standard exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children. The vPSG gives the obstructive apnea-hypopnea index (OAHI), necessary for the diagnosis of OSAS and to determine its severity. But the vPSG is a rather cumbersome exam, sometimes difficult to perform in children, with several sensors and electrodes to install on a child's body (electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), nasal cannula, thoracoabdominal belts, pulse oximetry, body position) that is time-consuming for installation and analysis. Video-respiratory polygraphy (vPG) is very similar to vPSG but without EEG, EOG and EMG electrodes. vPG represents an alternative for the diagnosis of OSAS. However, these sleep examinations, vP(S)G, requires a number of electrodes and sensors to be installed on the child's body and one night of hospitalization.

The desaturation index obtained by simple portable oximetry could be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. Portable oximetry is an easier test to perform. It is better accepted by the child because it only requires a finger or toe sensor and could be done on an outpatient basis or in the hospital.

The coupling of these 2 examinations, vP(S)G and oximetry, is part of our current routine practice. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify an OSAS in children.

Study Type

Observational

Enrollment (Anticipated)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Vandoeuvre-lès-Nancy, France, 54500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children who underwent a vP(S)G simultaneously with oximetry during the period June 2017 to June 2022. Data of vP(S)G and of oximetry are retrospectively collected from the hospital recording of children who underwent these exams.

Description

Inclusion Criteria:

Children aged 2 to 18 years suspected of OSA who underwent a vP(S)G simultaneously with oximetry during the period June 2017 to June 2022.

Exclusion Criteria:

Children with non-interpretable recordings

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation index is different in moderate-severe OSAS
Time Frame: Baseline
The number of desaturations per hour of recording obtained by oximetry between children with moderate-severe OSAS (defined as OAHI ≥ 5/h of sleep on the vP(S)G) and children without OSAS/with mild OSAS (defined as OAHI < 5/h of sleep )
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of desaturation index
Time Frame: Baseline
Sensitivity and specificity of the number of desaturations per hour if recording obtained by oximetry alone for the identification of children with moderate-severe OSAS (defined as an OAHI ≥ 5 /h of sleep in vP(S)G).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Iulia IOAN, MD PhD, CHRU de NANCY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 2, 2023

Primary Completion (Anticipated)

January 3, 2023

Study Completion (Anticipated)

January 15, 2023

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Estimate)

January 2, 2023

Last Update Submitted That Met QC Criteria

December 29, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI161-318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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