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Clinical Trials in France / NCT07136909
Recruiting Observational

Validation of the French Version of the OSA-18 Questionnaire

NCT07136909 · tracked via the Priya Life Science France tracker
Sponsor
Hospices Civils de Lyon
Phase
Observational
Started
2026-06-29
Last updated
2026-07-01

Condition(s) studied

Apnea, Obstructive

Investigational drug(s) / intervention(s)

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

Study summary

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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Scores on the French version of the OSA-18 questionnaire (total score) — Day 2
    The OSA-18 questionnaire will be filled-in by caregivers.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Femme-Mère-Enfant Bron Rhône Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07136909 on ClinicalTrials.gov ↗ ← All trials in France