Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 10:44 PM
Study NCT ID:
NCT05999461
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2023-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Auditory Dysfunction With Retinal Ischemia in Behcet Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2023-08-12', 'studyFirstSubmitQcDate': '2023-08-12', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of hearing abnormalities in behcet disease', 'timeFrame': '3 MONTHS', 'description': 'pure tone audiometry, tympanogram and acoustic reflex'}, {'measure': 'correlation of hearing abnormalities with retinal ischemia', 'timeFrame': '3 months', 'description': 'oct angiography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Behcet's Disease With Multisystem Involvement"]}, 'descriptionModule': {'briefSummary': "Auditory dysfunction is commonly detected in Behçet's disease (BD). Also, vestibular abnormalities as well as cochlear function affection have been found. The inflammatory process in BD may be the cause of audiometry abnormalities in those patients. The aim of this study is to assess hearing dysfunction in Behçet patients and its relation to retinal ischemia and disease activity using conventional pure-tone audiometry (cPTA), tympanogram and acoustic reflex", 'detailedDescription': 'pure tone audiometry is a behavioral test used to measure hearing sensitivity. This measure involves the peripheral and central auditory systems. Pure-tone thresholds (PTTs) indicate the softest sound audible to an individual at least 50% of the time. Hearing sensitivity is plotted on an audiogram, which displays intensity as a function of frequency.\n\nSpeech audiometry employs speech signals to assess if the patient has problems hearing speech or speech in noise. Speech audiometry can be used to examine the processing ability and if it is affected by disorders of the middle ear, cochlea, auditory nerve, brainstem pathway, or auditory centers of the cortex.\n\nTympanogram is a test of middle ear functioning. This objective test also allows to view the functioning of the Eustachian Tube, the upper auditory pathways and the reflex contraction from the middle ear muscles. Impedance testing is crucial in distinguishing a conductive loss from a sensorineural hearing loss.\n\nOptical coherence tomography angiography (OCT-A) for imaging the microvasculature of the retina and the choroid.\n\nBehcet disease current activity form for assessment of disease activity range from 0 to 12 . 12 represents the highest disease activity. It depends on the symptoms present over the last 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study subjects consist of 2 groups. the first group is behcet patients that fulfill the International Criteria of behcet disease. second group consists of age and sex matched healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients fulfill the International Criteria of behcet disease\n\nExclusion Criteria:\n\n* age more than 50\n* ear infection,\n* ear trauma, acoustic trauma, or usage of ototoxic drugs.\n* Also, associated systemic diseases that can affect the hearing as infectious diseases (e.g., mumps, CMV), granulomatous diseases (e.g., sarcoidosis, Wegner's granulomatosis), other autoimmune diseases (e.g., Rheumatoid arthritis, Cogan's syndrome, polyarteritis nodosa, relapsing polychondritis), and diseases of the bone (e.g., Paget's disease)."}, 'identificationModule': {'nctId': 'NCT05999461', 'briefTitle': 'Association of Auditory Dysfunction With Retinal Ischemia in Behcet Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Association of Auditory Dysfunction With Retinal Ischemia in Behcet Disease', 'orgStudyIdInfo': {'id': 'behcet disease'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases', 'description': 'behcet patients'}, {'label': 'control', 'description': 'age and sex matched healthy volunteers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Maha Sayed Ibrahim Abdelrahman', 'investigatorAffiliation': 'Assiut University'}}}}