Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events

NCT ID: NCT03817762

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-08-01

Brief Summary

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The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement. The automatic analysis of respiratory events has never been evaluated in a pediatric population. The primary objective of this study was to determine the feasibility of pediatric RP in an ENT department routine practice. The second objective was to evaluate the reliability of the automatic signal analysis in children.

Detailed Description

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Retrospective single center study of 50 children (32 boys and 18 girls, mean age 5.5 ± 2.3 years) who benefited from an overnight RP in an ENT hospitalization department between January and August 2016 for OSAS suspicion. Manual detection of respiratory events was performed by the same ENT specialist, and compared to the automatic analysis.

Conditions

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Obstructive Sleep Apnea Hypopnea Syndrome

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age between 2 and 12 years
* child having performed a ventilatory polygraph for suspicion of obstructive hypopnoea apnea syndrome

Exclusion Criteria

\- over 12 years old
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed AKKARI, MD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL17_0450

Identifier Type: -

Identifier Source: org_study_id

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