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NCT Number: NCT07136909

Validation of the French Version of the OSA-18 Questionnaire

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.

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Key information

Conditions

Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Scores on the French version of the OSA-18 questionnaire (total score)

    Time frame: Day 2

    The OSA-18 questionnaire will be filled-in by caregivers.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore GUYON

CONTACT

[email protected]

04 27 85 52 47 ext. +33

Patricia FRANCO, MD

CONTACT

[email protected]

04 27 85 60 52 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: French OSA18

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 22, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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