Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT04117620
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2019-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004244', 'term': 'Dizziness'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073222', 'term': 'Patient Health Questionnaire'}], 'ancestors': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reproducibility', 'timeFrame': '1 year', 'description': 'Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.'}, {'measure': 'Consistency reliability test', 'timeFrame': '1 year', 'description': 'Measure of efficiency. Comparison of questionnaires completed by patients and controls.'}, {'measure': 'Item-total Pearson correlation', 'timeFrame': '1 year', 'description': 'Measure of efficiency. Comparison of questionnaires completed by patients and controls.'}, {'measure': 'Principal components analysis', 'timeFrame': '1 year', 'description': 'Measure of efficiency. Comparison of questionnaires completed by patients and controls.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric vestibular symptom', 'Pediatric vestibular symptom questionnaire in french'], 'conditions': ['Dizziness']}, 'referencesModule': {'references': [{'pmid': '37225531', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients followed by the department of otolaryngology and cervico-facial surgery of Necker-Enfants Malades hospital and siblings for the control subjects.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-opposition of the holders of parental authority and the subject to participation in the study\n* Subjects between 7 and 17 years of age\n* 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.\n* Controls : subject with no vestibular deficiency, symptoms of balance disorder, migraine, otological pathology or ophthalmological disorder at the time of inclusion or background.\n\nExclusion Criteria:\n\n\\- Absence of diagnosis after etiological assessment.'}, 'identificationModule': {'nctId': 'NCT04117620', 'acronym': 'QEV-FR', 'briefTitle': "Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire", 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': "Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire", 'orgStudyIdInfo': {'id': 'APHP190616'}, 'secondaryIdInfos': [{'id': 'ID RCB : 2019-A00364-53', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients from 7 to 17 years of age with vestibular deficiency.', 'interventionNames': ['Other: Pediatric Vestibular Symptom Questionnaire']}, {'label': 'Controls', 'description': 'Subjects from 7 to 17 years of age without vestibular deficiency', 'interventionNames': ['Other: Pediatric Vestibular Symptom Questionnaire']}], 'interventions': [{'name': 'Pediatric Vestibular Symptom Questionnaire', 'type': 'OTHER', 'otherNames': ['Patient questionnaire'], 'description': 'Subjects respond to the translated questionnaire twice with 15 days interval', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP, Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'François Simon, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}