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Validity of the French Version of the Child's Vertigo Questionnaire (QEV-FR)

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ClinicalTrials.gov Identifier: NCT04117620
Recruitment Status : Not yet recruiting
First Posted : October 7, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment
Dizziness Other: Pediatric Vestibular Symptom 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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validity of the French Version of the Child's Vertigo Questionnaire
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients
Patients from 7 to 17 years of age with vestibular deficiency.
Other: Pediatric Vestibular Symptom Questionnaire
Subjects respond to the translated questionnaire twice with 15 days interval
Other Name: Patient questionnaire

Controls
Subjects from 7 to 17 years of age without vestibular deficiency
Other: Pediatric Vestibular Symptom Questionnaire
Subjects respond to the translated questionnaire twice with 15 days interval
Other Name: Patient questionnaire




Primary Outcome Measures :
  1. Reproducibility [ Time Frame: 1 year ]
    Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.

  2. Consistency reliability test [ Time Frame: 1 year ]
    Measure of efficiency. Comparison of questionnaires completed by patients and controls.

  3. Item-total Pearson correlation [ Time Frame: 1 year ]
    Measure of efficiency. Comparison of questionnaires completed by patients and controls.

  4. Principal components analysis [ Time Frame: 1 year ]
    Measure of efficiency. Comparison of questionnaires completed by patients and controls.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed by the department of otolaryngology and cervico-facial surgery of Necker-Enfants Malades hospital and siblings for the control subjects.
Criteria

Inclusion Criteria:

  • 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

Controls :

- Subject with no vestibular deficiency, symptoms of balance disorder, migraine, otological pathology or ophthalmological disorder at the time of inclusion or background

Exclusion Criteria:

Over age of 18


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117620


Contacts
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Contact: François Simon, MD MSc +33144381872 f.simon@aphp.fr
Contact: Hélène Morel +33171196346 helene.morel@aphp.fr

Locations
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France
AP-HP, Hôpital Necker-Enfants Malades Not yet recruiting
Paris, France, 75015
Contact: François Simon, MD MSc    +33144381872    f.simon@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sub-Investigator: Marine Parodi, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: François Simon, MD MSc Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04117620     History of Changes
Other Study ID Numbers: APHP190616
ID RCB : 2019-A00364-53 ( Other Identifier: ANSM )
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pediatric vestibular symptom
Pediatric vestibular symptom questionnaire in french
Additional relevant MeSH terms:
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Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders