Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-04-08 @ 1:40 PM
Study NCT ID:
NCT02723695
Status:
UNKNOWN
Last Update Posted:
2016-03-30
First Post:
2016-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perception and Equilibrium After Cochlear Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003638', 'term': 'Deafness'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-24', 'studyFirstSubmitDate': '2016-03-24', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in postural perception of the gravitational vertical', 'timeFrame': 'One year', 'description': 'The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).\n\nThe measure is the average difference between the gravitational vertical and the tilt of the platform (in degree) over 20 trials.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in visual perception of the gravitational vertical', 'timeFrame': 'One year', 'description': 'The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).\n\nThe measure is the average difference between the gravitational vertical and the tilt of the rod (in degree) over 20 trials.'}, {'measure': 'Change from baseline in dynamic balance control', 'timeFrame': 'One year', 'description': 'The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).\n\nThe composite equilibrium (%) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA).'}, {'measure': 'Change from baseline in quiet standing within a specific sound environment', 'timeFrame': 'One year', 'description': 'The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).\n\nThe area covered by the centre of pressure in static posturography (eyes open and eyes closed) is calculated during trials within a specific and controled sound environment \\[quiet - implant OFF, quiet - implant ON, white noise (70 dB) - implant ON, the semantic content (70 dB) - implant OFF\\]'}, {'measure': 'Change from baseline in vestibular function', 'timeFrame': 'One year', 'description': 'The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).\n\nVestibular function is quantified by means of videonystagmography (pendular and caloric tests)'}, {'measure': 'Change from baseline in speech recognition', 'timeFrame': 'One year', 'description': 'The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).\n\nSpeech recognition (in %) is quantified with cochlear phonemic lists of Lafon at 70 dB with and without leep reading.'}, {'measure': 'Change from baseline in quality of life', 'timeFrame': 'One year', 'description': 'The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).\n\nScore of the quality of life (QoL) questionnaire (WHOQOL-BREF).'}, {'measure': 'Change from baseline in dizziness', 'timeFrame': 'One year', 'description': 'The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).\n\nSelf-rated score of the Dizziness Handicap Inventory (DHI).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cochlear implant', 'Perception', 'Posture', 'Quality of life'], 'conditions': ['Deafness']}, 'descriptionModule': {'briefSummary': "The cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can induce dizziness, balance and perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic interactions could alter the balance control and the visual and postural spatial orientation perceptions.\n\nThe usual treatment includes the monitoring of the patient's quality of life, of the vestibular function and of hearing. This study adds an assessment of spatial orientation and of posture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Profound deaf patients who are scheduled for a cochlear implantation\n* Patients gave their written informed consent\n* Patients are affiliated to the french social welfare\n\nExclusion Criteria:\n\n* Disorders from the motor and/or somesthetic systems (especially the lower limbs)\n* Contraindications to the scheduled functional assessments'}, 'identificationModule': {'nctId': 'NCT02723695', 'acronym': 'ORIENTIMPLANT', 'briefTitle': 'Perception and Equilibrium After Cochlear Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Assessment of Perceptual and Postural Performances Following a Cochlear Implantation', 'orgStudyIdInfo': {'id': '2013-A01086-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'Surgery (cochlear implantation)', 'interventionNames': ['Other: Evaluation of postural performances']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Controls', 'description': 'Asymptomatic subjects', 'interventionNames': ['Other: Evaluation of postural performances']}], 'interventions': [{'name': 'Evaluation of postural performances', 'type': 'OTHER', 'description': 'Postural tests', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile Parietti-Winkler, MD, PhD', 'role': 'CONTACT', 'email': 'c.parietti@chu-nancy.fr', 'phone': '+33 383 852 032'}, {'name': 'Bettina Montaut-Verient, MD', 'role': 'CONTACT', 'email': 'b.montaut-verient@chu-nancy.fr', 'phone': '+33 383 851 568'}, {'name': 'Cécile Parietti-Winkler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Philippe Perrin, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bettina Montaut-Verient, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Cécile Parietti-Winkler, MD, PhD', 'role': 'CONTACT', 'email': 'c.parietti@chu-nancy.fr', 'phone': '+33 383 852 032'}, {'name': 'Bettina Montaut-Verient, MD', 'role': 'CONTACT', 'email': 'b.montaut-verient@chu-nancy.fr', 'phone': '+33 383 851 568'}], 'overallOfficials': [{'name': 'Cécile Parietti-Winkler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lorraine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University Professor - Hospital Practitioner', 'investigatorFullName': 'Cecile PARIETTI-WINKLER', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}