Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT04860193
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2021-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Audio Vestibular Functions in COVID 19 Patients in Sohag Governate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-24', 'releaseDate': '2024-12-08'}], 'estimatedResultsFirstSubmitDate': '2024-12-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2021-04-18', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Basic audiological evaluation:', 'timeFrame': '3 months after infection', 'description': 'Pure-tone audiometry.'}, {'measure': 'Basic audiological evaluation:', 'timeFrame': '3 months after infection', 'description': 'Acoustic immittance testing'}, {'measure': 'Basic audiological evaluation:', 'timeFrame': '3 months after infection', 'description': 'Speech audiometry'}, {'measure': 'Auditory evoked potentials:', 'timeFrame': '3 months after infection', 'description': 'Auditory brainstem response.'}, {'measure': 'Auditory evoked potentials', 'timeFrame': '3 months after infection', 'description': 'P300'}, {'measure': 'Effect on vestibular functions', 'timeFrame': '3 months after infection', 'description': 'Videonystagmography'}, {'measure': 'Effect on vestibular functions', 'timeFrame': '3 months after infection', 'description': 'Video Head Implus test VHIT.'}, {'measure': 'Effect on vestibular functions', 'timeFrame': '3 months after infection', 'description': 'Vestibular evoked myogenic potential.'}, {'measure': 'Effect on vestibular functions', 'timeFrame': '3 months after infection', 'description': 'Computerized Dynamic Posturography (CDP)'}], 'secondaryOutcomes': [{'measure': 'Effect on cognitive functions', 'timeFrame': '3 months after infection', 'description': 'Cognitive function assessment:\n\nBy Montreal test'}, {'measure': 'Vestibular questionnaire', 'timeFrame': '3 months after infection', 'description': 'Dizziness Handicap Inventory (DHI).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID19']}, 'descriptionModule': {'briefSummary': 'There is evidence that up to 30% of COVID-19 patients was reported with neurological manifestations such as impaired consciousness, headache, and dizziness have been reported in COVID-19 patients in addition, olfactory and taste alterations are common symptoms in patients affected by COVID-19.This study will be conducted to evaluate the effect of the novel coronavirus on audio-vestibular functions in confirmed COVID19 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The present study will include 100 of randomly selected patients who were had been confirmed to be infection with COVID 19 virus, age ranged from 20-50 years. The investigation will be done three months after infection and after being sure that the patient become noninfectious.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Well educated patients Age: range between 20 to 50 years No previous history of hearing loss or otoneurologic disease\n\nWell confirmed COVID 19 patients:\n\npatients who were diagnosed with coronavirus from\n\n* symptoms: fever, cough, generalized malaise, dyspnea.\n* Laboratory finding: abnormalities have been observed in Complete blood count (CBC), high C-reactive protein and ferritin, elevated D-dimer.\n* Imaging: Chest CT scan: bilateral ground glass opacities, crazy paving, and consolidation.\n* nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction testing (RT-PCR).\n\nExclusion Criteria:\n\n* previous history of hearing loss or otoneurological disease'}, 'identificationModule': {'nctId': 'NCT04860193', 'briefTitle': 'Audio Vestibular Functions in COVID 19 Patients in Sohag Governate', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Audiovestibular Functions in Covid 19 Patients in Sohag Governate', 'orgStudyIdInfo': {'id': 'Soh-Med-21-04-14'}}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Yasmeen Mohamed', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Yasmeen Ali Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-12-08', 'type': 'RELEASE'}, {'date': '2025-01-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yasmeen Ali Mohamed, Principal investigator, Sohag University'}}}}