Validation of the French Version of the OSA-18 Questionnaire
ConditionApnea, Obstructive
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-17
SponsorHospices Civils de Lyon
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Parents and/or children object to participation in the study.
Subjects participating in another intervention research study with an ongoing exclusion period.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Completion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care.
Other interventionCompletion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Children referred to the sleep clinic for polysomnography.1 intervention
Trial outcomes
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.
Time frame
Day 2Sponsors and contacts
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Source ClinicalTrials.gov