DizzinessQEV-FRNCT04117620
Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire
An observational study of Dizziness, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
There is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Dizziness
- What is being tested?
- Pediatric Vestibular Symptom Questionnaire
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2020to 28 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients followed by the department of otolaryngology and cervico-facial surgery of Necker-Enfants Malades hospital and siblings for the control subjects.
Who may be able to join
- Non-opposition of the holders of parental authority and the subject to participation in the study
- Subjects between 7 and 17 years of age
- Patients : patients followed in the clinic at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery and presenting with dizziness without associated ophthalmological or neurological disorder.
- Controls : subject with no vestibular deficiency, symptoms of balance disorder, migraine, otological pathology or ophthalmological disorder at the time of inclusion or background.
Who cannot join
- Absence of diagnosis after etiological assessment.
Trial locations and contacts
1 site in 1 country.
About this study
There is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.
Read the detailed description
Balance disorders are the most common cause of dizziness in children with a prevalence of 0.7 to 15%. Vestibular migraine, benign paroxysmal positional vertigo of the child, post-concussion dizziness as a result of cranial trauma, and viral vestibular neuritis are the most common causes. However, these disorders are often undiagnosed in children as many doctors may attribute these symptoms to behavioural disorders or clumsiness. This is probably because of the difficulty children may have in expressing or describing their dizziness symptoms without specific questioning, but also because of the tendency of children to accept the terminology that an adult offers them or even tend to cling to their parents when they experience a balance disorder or vertigo. Vestibular disorders can also have secondary psychological symptoms with an impact on school learning and quality of life. A precise interrogation to check the symptoms, to look for the triggers and to trace the installation of the symptoms is fundamental to diagnose and make a therapeutic decision. Thus, it is very important to help the child express his or her feelings by proposing different descriptions and formulations to determine the etiology and diagnosis. While a number of international questionnaires validated and translated into French exist in the adult to assess the presence, severity and impact of vestibular symptoms, there is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.
- Conditions
- Dizziness
- Being tested
- Pediatric Vestibular Symptom Questionnaire
- Keywords
- Pediatric vestibular symptom, Pediatric vestibular symptom questionnaire in french
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Vestibular Symptom QuestionnaireOther
Also called Patient questionnaire
Subjects respond to the translated questionnaire twice with 15 days interval
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients from 7 to 17 years of age with vestibular deficiency. Receives: Other: Pediatric Vestibular Symptom Questionnaire | |
| Controls | Subjects from 7 to 17 years of age without vestibular deficiency Receives: Other: Pediatric Vestibular Symptom Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility
Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.
Measured: 1 year
Consistency reliability test
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Measured: 1 year
Item-total Pearson correlation
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Measured: 1 year
Principal components analysis
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start28 Apr 2020
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- François Simon, MD MSc, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117620
- Sponsor's protocol ID
- APHP190616
- Other IDs
- ID RCB : 2019-A00364-53
- Acronym
- QEV-FR
- Status last verified
- Sep 2025
- First submitted
- 3 Oct 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rigal T, Parodi M, Brisse F, Denoyelle F, Loundon N, Simon F. Translation and validation of the PVSQ and DHI-PC questionnaires for pediatric dizziness. Eur Ann Otorhinolaryngol Head Neck Dis. 2024 Jan;141(1):5-12. doi: 10.1016/j.anorl.2023.05.001. Epub 2023 May 22.
PubMed 37225531
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire
- ClinicalTrials.gov ID
- NCT04117620
- Acronym / sponsor ID
- QEV-FR / APHP190616
- Conditions
- Dizziness
- Keywords
- Pediatric vestibular symptom, Pediatric vestibular symptom questionnaire in french
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 7 Oct 2019 (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.
There is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.
Detailed description
Balance disorders are the most common cause of dizziness in children with a prevalence of 0.7 to 15%. Vestibular migraine, benign paroxysmal positional vertigo of the child, post-concussion dizziness as a result of cranial trauma, and viral vestibular neuritis are the most common causes. However, these disorders are often undiagnosed in children as many doctors may attribute these symptoms to behavioural disorders or clumsiness. This is probably because of the difficulty children may have in expressing or describing their dizziness symptoms without specific questioning, but also because of the tendency of children to accept the terminology that an adult offers them or even tend to cling to their parents when they experience a balance disorder or vertigo. Vestibular disorders can also have secondary psychological symptoms with an impact on school learning and quality of life. A precise interrogation to check the symptoms, to look for the triggers and to trace the installation of the symptoms is fundamental to diagnose and make a therapeutic decision. Thus, it is very important to help the child express his or her feelings by proposing different descriptions and formulations to determine the etiology and diagnosis. While a number of international questionnaires validated and translated into French exist in the adult to assess the presence, severity and impact of vestibular symptoms, there is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Pediatric Vestibular Symptom QuestionnairePatients from 7 to 17 years of age with vestibular deficiency. |
| Controls | – | Other: Pediatric Vestibular Symptom QuestionnaireSubjects from 7 to 17 years of age without vestibular deficiency |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients followed by the department of otolaryngology and cervico-facial surgery of Necker-Enfants Malades hospital and siblings for the control subjects.
Key inclusion criteria (4 listed)
- Non-opposition of the holders of parental authority and the subject to participation in the study
- Subjects between 7 and 17 years of age
- Patients : patients followed in the clinic at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery and presenting with dizziness without associated ophthalmological or neurological disorder.
- Controls : subject with no vestibular deficiency, symptoms of balance disorder, migraine, otological pathology or ophthalmological disorder at the time of inclusion or background.
Key exclusion criteria (1 listed)
- Absence of diagnosis after etiological assessment.
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 |
|---|---|---|
| Pediatric Vestibular Symptom QuestionnaireAlso: Patient questionnaireSubjects respond to the translated questionnaire twice with 15 days interval | Other | Controls, Patients |
Primary outcome
Reproducibility
Time frame: 1 year
Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.
Consistency reliability test
Time frame: 1 year
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Item-total Pearson correlation
Time frame: 1 year
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Principal components analysis
Time frame: 1 year
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 37225531Rigal T, Parodi M, Brisse F, Denoyelle F, Loundon N, Simon F. Translation and validation of the PVSQ and DHI-PC questionnaires for pediatric dizziness. Eur Ann Otorhinolaryngol Head Neck Dis. 2024 Jan;141(1):5-12. doi: 10.1016/j.anorl.2023.05.001. Epub 2023 May 22.
- 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. This study is not recruiting at the moment.
François Simon, MD MSc principal investigator
Assistance Publique - Hôpitaux de Paris
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 Dizziness, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 12 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117620, which also lists 1 linked publication.
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 12 Sep 2025.