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Trials / Not Yet Recruiting

Not Yet RecruitingNCT07136909

Validation of the French Version of the OSA-18 Questionnaire

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
4 Years – 17 Years
Healthy volunteers

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

Interventions

TypeNameDescription
OTHERCompletion 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.

Timeline

Start date
2025-11-01
Primary completion
2027-04-01
Completion
2027-04-01
First posted
2025-08-22
Last updated
2025-08-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07136909. Inclusion in this directory is not an endorsement.