Not yet recruitingOBSERVATIONAL

Validation of the French Version of the OSA-18 Questionnaire

This study is about a health problem called obstructive sleep apnoea (OSA), where children briefly stop breathing during sleep. This can affect their heart and learning. Doctors use a questionnaire, OSA-18, to help understand a child's symptoms and how OSA affects them. This questionnaire is currently not available in French. Therefore, this study aims to create a reliable French version of the OSA-18 questionnaire. Once completed, this French version will help doctors in French-speaking areas better assess and manage OSA in children. Parents will complete the questionnaire for their child while they are in hospital for routine check-ups related to sleep problems. The goal is to make sure this new French tool is accurate compared to standard sleep tests.

At a glance

Status

Not yet recruiting

Sponsor

Hospices Civils de Lyon

Enrolment target

200

Start

01 Nov 2025

Estimated completion

01 Apr 2027

Apnea, Obstructive

What is this study about?

Obstructive sleep apnoea (OSA) is a common condition where a child's breathing stops and starts repeatedly during sleep. This happens because their airway partly or fully closes. It can lead to them not getting enough oxygen and their sleep being disturbed. For children, OSA can have serious effects on their heart health and how their brain develops and learns. That's why it's really important for doctors to spot OSA early and treat it effectively.

To help with this, there's a special questionnaire called OSA-18. It asks questions that help parents describe their child's sleep problems and how OSA affects their daily life. This questionnaire is used to give doctors a clearer picture than just answering simple yes or no questions. It helps them understand the full impact of OSA.

Currently, this useful questionnaire isn't available in French. This study aims to create a French version and make sure it works just as well as the original. The main goal is to check that the French OSA-18 is accurate when compared to the most reliable sleep test, called polysomnography. If successful, this new French questionnaire will be a valuable tool for doctors to assess children with OSA, not just in studies but also in their everyday practice, helping to track if treatments are working.

Key takeaways

A new French questionnaire for children's sleep apnoea is being developed.
This questionnaire (OSA-18) helps doctors understand sleep problems.
The study checks if the French version is accurate.
Participation involves filling out a questionnaire during a hospital stay.
Its aim is to improve care for children with sleep apnoea.
Suitable for children aged 4-17 already undergoing sleep tests.

Who may be eligible?

This study is looking for children who are already in hospital because their doctors want to check them for obstructive sleep apnoea (OSA) using a special sleep test called polysomnography. They must be aged between 4 and 17 years old, inclusive.

Children cannot take part if their parents, or the children themselves, don't want to. Also, if a child is already involved in another research study that has a specific waiting period before joining a new one, they won't be able to join this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 4 and 17 years old?
Is your child currently in hospital for a sleep study (polysomnography) to check for sleep apnoea?
Are you, as the parent, happy for your child to take part?
Is your child also happy to take part?
Is your child currently NOT involved in another research study with specific participation restrictions?
Are you able to complete a questionnaire in French?

Answer every question to see your result.

What does participation involve?

If your child is eligible and you agree to take part, your role would simply be to complete the OSA-18 questionnaire. This will happen during a time when your child is already in the hospital for routine checks for their sleep problems. There are no extra hospital visits or special appointments required just for this study. Your child won't need to take any new medication or have any additional tests or procedures. The study is focused on how well the French version of the questionnaire reflects what doctors find with standard sleep tests. It's a one-off completion of the questionnaire, so there's no ongoing follow-up specifically for this study.

Potential risks and benefits

Taking part in this study involves very little risk for you or your child, as it only requires completing a questionnaire that is already widely used. There are no medical procedures or changes to your child's treatment involved. A potential benefit is that by helping to validate this French questionnaire, you're contributing to a better understanding and assessment of sleep apnoea for other French-speaking children in the future. Remember, participating is completely voluntary, and you have the right to withdraw yourself or your child at any time without giving a reason, and it will not affect your child's ongoing medical care.

Locations (1)

Hôpital Femme-Mère-Enfant
Verified postcode
Bron, France

Common questions

What is obstructive sleep apnoea (OSA)?

OSA is a condition where a child's breathing stops and starts while they sleep, usually because their airway temporarily closes.

What is the OSA-18 questionnaire?

It's a questionnaire with 18 questions that parents fill out to describe their child's sleep problems and how OSA affects their life.

Why is this study needed?

This study aims to make a reliable French version of the OSA-18 questionnaire so doctors in French-speaking countries can use it effectively.

Will my child get any special treatment?

No, your child will only complete the questionnaire while already in hospital for their routine sleep tests. There are no extra treatments.

What does 'polysomnography' mean?

Polysomnography is a special sleep study that records what happens to your child's body during sleep, often called the 'gold standard' for diagnosing sleep problems.

How to find out more

Patricia FRANCO, MD

patricia.franco@chu-lyon.fr 04 27 85 60 52 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.