Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-10 @ 6:51 PM
Study NCT ID:
NCT04678167
Status:
RECRUITING
Last Update Posted:
2023-07-21
First Post:
2020-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020338', 'term': 'Vestibular Neuronitis'}], 'ancestors': [{'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002150', 'term': 'Caloric Tests'}], 'ancestors': [{'id': 'D014724', 'term': 'Vestibular Function Tests'}, {'id': 'D003939', 'term': 'Diagnostic Techniques, Otological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Only the investigator carrying out the follow-up consultations is blind.\n\nAfter examination by the ENT specialist (otorhinolaryngologist) who will diagnose vestibular neuritis, the patient will be randomized into one of three groups. The clinical follow-up will be performed by another practitioner, who will not know in which arm the patient is included (the patient will come to the consultation without his glasses). Only the practitioner who realized the randomization and the patient will have information about the arm in which they are located.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The randomization list is established by the Brest CHRU data management unit before the start of the trial. Based on a ratio (1:1:1) with stratification on the center.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2027-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2020-10-02', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of the angle of deviation at the Fukuda test between J0 and J7 (value at J0 minus value at J7).', 'timeFrame': '7 day'}], 'secondaryOutcomes': [{'measure': 'Speed of nystagmus', 'timeFrame': '1 year'}, {'measure': "Alexander's degree of nystagmus", 'timeFrame': '1 year', 'description': 'Measure of the degree of intensity of nystagmus. There are 3 degrees :\n\n* Degree I: nystagmus which exists only when the eyes are turned to the right.\n* Degree II: also exists when the eyes are to the right or to the front.\n* Degree Ill: exists when the eyes are on the right, front, or left.'}, {'measure': 'Duration of hospitalization (for hospitalized patients)', 'timeFrame': '1 year'}, {'measure': 'Anxiety visual analog scale', 'timeFrame': '1 year', 'description': '0 = no anxiety, 10 = maximum anxiety imaginable'}, {'measure': 'Handicap related to Balance Disorders and Vertigo scale (EHTEV questionnaire)', 'timeFrame': '1 year', 'description': 'It helps to determine the physical, emotional and functional difficulties experienced in everyday life. EHTEV questionnaire is scored on 100 points.\n\nThe physical score from 0 to 28 points, the emotional score from 0 to 36 points and the functional score from 0 to 36 points. ( 0 = no difficulty).'}, {'measure': 'European Vertigo Evaluation Scale (EEV questionnaire)', 'timeFrame': '1 year', 'description': 'Makes it possible to quantify vertigo and the associated vestibular symptoms and to monitor their evolution. EEV questionnaire is scored on 20 points (0 = no symptoms, 20 = maximum symptoms)'}, {'measure': 'Vestibular deficit at caloric tests', 'timeFrame': '1 year', 'description': 'measures 7of nystagmus (= fluttering of the eye) which reflects vestibular activity'}, {'measure': 'Variation from J0 of the angle of deviation at the Fukuda measured at J14, M1, M3, M6, M12', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vestibular hyporeflexia', 'rotational vertigo', 'horizontal-rotational nystagmus'], 'conditions': ['Vestibular Neuritis']}, 'descriptionModule': {'briefSummary': 'Vestibular neuritis is a brutal and continuous dizzying syndrome of peripheral (vestibular) origin without cochlear or other associated involvement. Specifically, vestibular neuritis is inflammation of the nerve that innervates the vestibular canals (the inner ear). It is characterized by the sudden onset of intense and prolonged vertigo accompanied by postural imbalance, nausea and vomiting, without hearing impairment or other neurological symptoms. Vestibular neuritis is the second cause of peripheral vertigo after benign paroxysmal positional vertigo. It represents approximately 7% of patients consulting for vertigo. The purpose of this study is to evaluate if wearing Boarding Ring glasses can be accelerated vestibular compensation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients,\n* patient with vestibular neuritis defined by appearance of continuous rotating vertigo with nausea\n* patient with spontaneous horizonto-rotating nystagmus beating towards the healthy ear\n* patient with a postural deviation towards the affected ear;\n* vestibular hyporeflexia measured at the caloric tests greater than 25%\n* patient who has given free, enlighten and written consent\n\nExclusion Criteria:\n\n* patient with a history of vertigo of vestibular origin or with vertigo developing for more than 4 days\n* patient with associated hearing loss or tinnitus\n* patient with an motor ocular abnormality of central origin\n* patient refusal or inability to consent'}, 'identificationModule': {'nctId': 'NCT04678167', 'acronym': 'NEVRING', 'briefTitle': 'Boarding Ring Glasses Versus Placebo Glasses or Not Glasses in the Treatment of Vestibular Neuritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Evaluation of the Efficacy of BOARDING RING Glasses in the Treatment of Vestibular Neuritis', 'orgStudyIdInfo': {'id': '29BRC20.0040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boarding ring glasses', 'description': "Realization of the following examinations WITH Boarding ring glasses :\n\n* caloric tests,\n* measurement of the speed of Nystagmus,\n* angle of deviation in Fukuda,\n* Alexander's degree of nystagmus,\n* EHTEV and EEV questionnaires,\n* anxiety VAS", 'interventionNames': ['Diagnostic Test: Caloric test', 'Diagnostic Test: Measurement of the speed of Nystagmus', 'Diagnostic Test: Angle of deviation at Fukuda', "Diagnostic Test: Alexander's degree of nystagmus", 'Other: EHTEV questionnaire', 'Other: EEV questionnaire', 'Other: anxiety VAS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo glasses', 'description': "Realization of the following examinations WITH Placebo glasses :\n\n* caloric tests,\n* measurement of the speed of Nystagmus,\n* angle of deviation in Fukuda,\n* Alexander's degree of nystagmus,\n* EHTEV and EEV questionnaires,\n* anxiety VAS", 'interventionNames': ['Diagnostic Test: Caloric test', 'Diagnostic Test: Measurement of the speed of Nystagmus', 'Diagnostic Test: Angle of deviation at Fukuda', "Diagnostic Test: Alexander's degree of nystagmus", 'Other: EHTEV questionnaire', 'Other: EEV questionnaire', 'Other: anxiety VAS']}, {'type': 'OTHER', 'label': 'No glasses', 'description': "Realization of the following examinations WITHOUT glasses :\n\n* caloric tests,\n* measurement of the speed of Nystagmus,\n* angle of deviation in Fukuda,\n* Alexander's degree of nystagmus,\n* EHTEV and EEV questionnaires,\n* anxiety VAS", 'interventionNames': ['Diagnostic Test: Caloric test', 'Diagnostic Test: Measurement of the speed of Nystagmus', 'Diagnostic Test: Angle of deviation at Fukuda', "Diagnostic Test: Alexander's degree of nystagmus", 'Other: EHTEV questionnaire', 'Other: EEV questionnaire', 'Other: anxiety VAS']}], 'interventions': [{'name': 'Caloric test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Barany test'], 'description': 'Lying, patientwill be placed so that he can introduce water (hot then cold) into his external ear canal. It is the reaction of the vestibular system (sensory organ responsible for balance) which is then measured with a helmet placed over his eyes and which measures the nystagmus (movement of the eye) which reflects vestibular activity.', 'armGroupLabels': ['Boarding ring glasses', 'No glasses', 'Placebo glasses']}, {'name': 'Measurement of the speed of Nystagmus', 'type': 'DIAGNOSTIC_TEST', 'description': 'A helmet with an infrared camera will be placed in front of patient eyes. This will allow visualizing on screen and measuring eye movements spontaneous or induced in the dark by various tests.', 'armGroupLabels': ['Boarding ring glasses', 'No glasses', 'Placebo glasses']}, {'name': 'Angle of deviation at Fukuda', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patient will be asked to trample on the spot (30 steps) with the indexes pointed forward. In the event of vestibular asymmetry, the patient turns at a varying angle to the right or to the left. This will then measure what is called the angle of deflection of the fukuda.', 'armGroupLabels': ['Boarding ring glasses', 'No glasses', 'Placebo glasses']}, {'name': "Alexander's degree of nystagmus", 'type': 'DIAGNOSTIC_TEST', 'description': 'there are 3 degrees:\n\n* Degree I: nystagmus that exists only when the eyes are turned to the right.\n* Degree II: also exists when the eyes are to the right or to the front.\n* Degree Ill: exists when the eyes are on the right, front, or left', 'armGroupLabels': ['Boarding ring glasses', 'No glasses', 'Placebo glasses']}, {'name': 'EHTEV questionnaire', 'type': 'OTHER', 'description': 'Handicap Scale for Balance Disorders and Vertigo', 'armGroupLabels': ['Boarding ring glasses', 'No glasses', 'Placebo glasses']}, {'name': 'EEV questionnaire', 'type': 'OTHER', 'description': 'European Vertigo Assessment Questionnaire', 'armGroupLabels': ['Boarding ring glasses', 'No glasses', 'Placebo glasses']}, {'name': 'anxiety VAS', 'type': 'OTHER', 'description': 'visual analog scale of anxiety', 'armGroupLabels': ['Boarding ring glasses', 'No glasses', 'Placebo glasses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Christophe LECLERE, Dr', 'role': 'CONTACT', 'email': 'jean-christophe.leclere@chu-brest.fr', 'phone': '02.98.22.33.78'}], 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29672', 'city': 'Morlaix', 'status': 'TERMINATED', 'country': 'France', 'facility': 'CH Pays de Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}, {'zip': '29107', 'city': 'Quimper', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charlotte MISTRETTA', 'role': 'CONTACT', 'email': 'charlotte.mistretta@gmail.com'}, {'name': 'Charlotte MISTRETTA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH de Cornouaille Quimper', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}], 'centralContacts': [{'name': 'Jean-Christophe LECLERE, Dr', 'role': 'CONTACT', 'email': 'jean-christophe.leclere@chu-brest.fr', 'phone': '02.98.22.33.78'}], 'overallOfficials': [{'name': 'Jean-Christophe LECLERE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Brest'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending fifteen years following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}