Validation of the French Version of the OSA-18 Questionnaire

NCT07136909 | Recruiting

• 1 other identifier: 69HCL25_0721
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Apnea, Obstructive

Keywords

Obstructive sleep apnea; sleep disordered breathing; questionnaire

Outcome Measures

Primary Outcomes (1)

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

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

  Day 2

Study Arms (1)

Children referred to the sleep clinic for polysomnography.

Children aged 4 to 17 years referred hospitalized in the sleep unit of the Hospices Civils de Lyon (France) for polysomnography, for a duration of 24 to 48h.

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

Interventions

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.

Children referred to the sleep clinic for polysomnography.

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 4 to 17 years referred hospitalized in the sleep unit of the Hospices Civils de Lyon (France) for polysomnography, for a duration of 24 to 48h.

You may qualify if:

• 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.

You may not qualify if:

• Parents and/or children object to participation in the study.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme-Mère-Enfant

Bron, Rhône, 69500, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Patricia FRANCO, MD

CONTACT

04 27 85 60 52; patricia.franco@chu-lyon.fr

Aurore GUYON

CONTACT

04 27 85 52 47; aurore.guyon@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 22, 2025
• Study Start: June 29, 2026
• Primary Completion (Estimated): January 29, 2028
• Study Completion (Estimated): January 29, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)