Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-29 @ 4:35 PM
Study NCT ID:
NCT04395261
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2020-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wideband Tympanometry in Otitis Media With Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010034', 'term': 'Otitis Media with Effusion'}], 'ancestors': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2020-05-19', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resonance frequency', 'timeFrame': 'The same 1 day with the operation', 'description': 'Wideband resonance frequency was measured'}, {'measure': 'Absorbance', 'timeFrame': 'The same 1 day with the operation', 'description': 'Wideband absorbance of frequencies between 250-8000 Hz were measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Otitis Media With Effusion']}, 'descriptionModule': {'briefSummary': 'The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up.', 'detailedDescription': 'Purpose: Otitis media with effusion is an important problem in childhood. After proper diagnosis, generally 3 months of follow up has been recommended before surgical tympanostomy tube insertion. If the physician can estimate the status of the middle ear or fluid type better with a non-invasive method, we can suggest an early operation to these patients or decide to follow up more with no intervention. The purpose of the study is to compare the surgically confirmed middle ear effusions with wideband absorbance values and to differentiate them noninvasively before the operation.\n\nMethods: A total of 123 children that were followed 3 months and treated surgically with the diagnosis of OME were included. Eighty-two sex, age-matched children were tested as control with wideband tympanometry. Ears were divided into four groups according to findings in the operation: serous, mucoid, adhesive, empty. Resonance frequency, 226 Hz, 1000 Hz compliance, Wideband Peak pressure, Absorbance measurements used for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with otitis media with effusion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients were diagnosed by ear examination, pneumatic otoscopy, and type B tympanogram with 226 Hz tympanometry. They were followed for 3 months with proper medication. After 3 months if there was no change with ear examination and 226 Hz tympanometry, surgical ventilation tube insertion was offered.\n\nExclusion Criteria:\n\n* The patients with chronic ear diseases, ototoxic drug use, neurologic disease were excluded.'}, 'identificationModule': {'nctId': 'NCT04395261', 'briefTitle': 'Wideband Tympanometry in Otitis Media With Effusion', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'The Differential Diagnosis of Different Middle Ear Fluids in Otitis Media With Effusion by Wideband Tympanometry', 'orgStudyIdInfo': {'id': '3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 0', 'description': 'Patients were divided into groups according to observation in surgery Empty ear in operation', 'interventionNames': ['Diagnostic Test: Wideband Tympanometry']}, {'label': 'Group 1', 'description': 'Patients were divided into groups according to observation in surgery Serous fluid in operation', 'interventionNames': ['Diagnostic Test: Wideband Tympanometry']}, {'label': 'Group 2', 'description': 'Patients were divided into groups according to observation in surgery Mucoid fluid in operation', 'interventionNames': ['Diagnostic Test: Wideband Tympanometry']}, {'label': 'Group 3', 'description': 'Patients were divided into groups according to observation in surgery Adhesive tympanic membrane in operation', 'interventionNames': ['Diagnostic Test: Wideband Tympanometry']}, {'label': 'Group 4', 'description': 'Control group. Subjects with no otitis media with effusion', 'interventionNames': ['Diagnostic Test: Wideband Tympanometry']}], 'interventions': [{'name': 'Wideband Tympanometry', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['Group 0', 'Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Fazıl N Ardıç, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief of Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available in the university depository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Dr.', 'investigatorFullName': 'Fazıl Necdet Ardıç', 'investigatorAffiliation': 'Pamukkale University'}}}}