NCT07136909 Validation of the French Version of the OSA-18 Questionnaire
| NCT ID | NCT07136909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Apnea, Obstructive |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-06-29 |
| Primary Completion | 2028-01-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-06-29 with a primary completion date of 2028-01-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07136909 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 17 Years, studying Apnea, Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07136909 currently recruiting?
Yes, NCT07136909 is actively recruiting participants. Contact the research team at patricia.franco@chu-lyon.fr for enrollment information.
Where is the NCT07136909 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT07136909 clinical trial?
NCT07136909 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 200 participants.