Apnea, ObstructiveFrench OSA18NCT07136909
Validation of the French Version of the OSA-18 Questionnaire
An observational study of Apnea, Obstructive, run by Hospices Civils de Lyon at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Apnea, Obstructive
- What is being tested?
- Completion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care.
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2026to 29 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Parents and/or children object to participation in the study.
- Subjects participating in another intervention research study with an ongoing exclusion period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Femme-Mère-Enfant
Bron, Rhône, 69500
Patricia FRANCO, MD, 04 27 85 60 52 ext. +33, patricia.franco@chu-lyon.fr
Aurore GUYON, 04 27 85 52 47 ext. +33, aurore.guyon@chu-lyon.fr
About this study
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.
Read more
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
- Being tested
- Completion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care.
- Keywords
- Obstructive sleep apnea, sleep disordered breathing, questionnaire
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Completion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on the French version of the OSA-18 questionnaire (total score)
The OSA-18 questionnaire will be filled-in by caregivers.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start29 Jun 2026
- Primary completion29 Jan 2028 (estimated)
- Study completion29 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136909
- Sponsor's protocol ID
- 69HCL25_0721
- Acronym
- French OSA18
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the OSA-18 Questionnaire
- ClinicalTrials.gov ID
- NCT07136909
- Acronym / sponsor ID
- French OSA18 / 69HCL25_0721
- Conditions
- Apnea, Obstructive
- Keywords
- Obstructive sleep apnea, sleep disordered breathing, questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 29 Jan 2028 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children referred to the sleep clinic for polysomnography. | – | Other: Completion of the OSA-18 questionnaire by parents, during hospitalization planned as part of routine care.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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Parents and/or children object to participation in the study.
- Subjects participating in another intervention research study with an ongoing exclusion period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion 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. | Other | Children referred to the sleep clinic for polysomnography. |
Primary outcome
Scores on the French version of the OSA-18 questionnaire (total score)
Time frame: Day 2
The OSA-18 questionnaire will be filled-in by caregivers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, Obstructive, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia FRANCO, MD (04 27 85 60 52 ext. +33, patricia.franco@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on the French version of the OSA-18 questionnaire (total score) (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.