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Recruiting NCT07136909

Validation of the French Version of the OSA-18 Questionnaire

Observational Apnea, Obstructive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Completion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care..
Who it may be relevant to
Registry conditions: Apnea, Obstructive. Basic parameters: 4 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Obstructive sleep apnea (OSA) is characterized by repetitive partial and/or total closure of the upper airway during sleep, inducing oxygen desaturation and sleep disturbance. Its prevalence in the pediatric population is 1-5%. In children, OSA can have negative consequences on the cardiovascular system and on the neurocognitive development. It is essential to diagnose OSA and to treat it efficiently. The OSA-18 questionnaire assesses the symptômes of OSA in children and its repercussions. It is composed of 18 items scored on a Likert scale by caregivers. This system allows a more sensitive scoring than binary answers available in other questionnaires like the Pediatric Sleep Questionnaire. The OSA-18 questionnaire would thus be an interesting tool to use for evaluating treatment efficacy in interventional studies and in clinical practice. This questionnaire is not yet available in French. The main objective of this study is thus to evaluate the validity of a French version compared to the gold standard method to evaluate OSA: polysomnography.

Interventions

  • Other Completion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care.
    Completion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care.

Primary outcome measures

  • Scores on the French version of the OSA-18 questionnaire (total score) [Time frame: Day 2]

Eligibility criteria

Inclusion criteria

  • Children hospitalized in the Clinical Epileptology, Sleep Disorders, and Child Functional Neurology Department for polysomnography to screen for OSA,
  • Aged 4 to 17 years inclusive.

Exclusion criteria

  • Parents and/or children object to participation in the study.
  • Subjects participating in another intervention research study with an ongoing exclusion period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

France · 1 center
  • Hôpital Femme-Mère-Enfant — Bron

Identifiers

NCT: NCT07136909 · 69HCL25_0721

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗