Validation of the French Version of the OSA-18 Questionnaire (French OSA18)

Civil Hospices of Lyon

Status: Begins enrollment in 2 months

Conditions: Apnea, Obstructive

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

Study type: Observational

Funder types: Other

Identifiers

NCT07136909

69HCL25_0721

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Children referred to the sleep clinic for polysomnography.

Description:

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.

Treatment:

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