Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT05535634
Status:
RECRUITING
Last Update Posted:
2022-09-10
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sound Ear Check (SEC) in Hearing Diagnostics in Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D010034', 'term': 'Otitis Media with Effusion'}], 'ancestors': [{'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'}, {'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000158', 'term': 'Acoustic Impedance Tests'}], 'ancestors': [{'id': 'D006320', 'term': 'Hearing Tests'}, {'id': 'D003939', 'term': 'Diagnostic Techniques, Otological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SNR', 'timeFrame': '1-2 months', 'description': 'Signal to noise ratio'}], 'secondaryOutcomes': [{'measure': 'Otitis media 6 questionnaire', 'timeFrame': '1-2 months', 'description': 'questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss', 'Otitis Media With Effusion', 'Tympanostomy']}, 'descriptionModule': {'briefSummary': 'Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit.', 'detailedDescription': 'Sound Ear Check (SEC) is an automated tablet-based self-test that uses common nonspeech sounds (ecological sounds) that are accompanied by pictures that are easily recognizable even for younger children.\n\nBefore TTI operation, each participant will be tested with SEC using normal (dichotic) sounds and antiphasic sounds. Results will be compared to middle ear findings and the test will be repeated one month after the operation when the middle ears are checked to be dry (with a ventilation tube). At the time of the myringotomy during TTI operation, possible middle ear fluid will be classified as serous (transparent, clear), mucous (thick) or purulent (consisting of pus). A tympanometry will be performed within the same visit as the SEC measurement before the TTI operation. At the time of tympanometric examination, each participant will be classified as cooperative (sittings still, not crying, not resisting) or non-cooperative. Tympanometric findings will be classified after the Jerger classification. SEC and tympanometric testing is designed to be performed at the same visit as TTI operation as patients will be waiting for the operation at the ward. Medical history of the study patients will be collected from the hospital patient records and through interview and questionnaires to the subjects. Ear related quality of life questionnaire (OM-6) will be performed at the beginning of the study and the one month control visit. Questionnaires are collected using web-based REDCap -software (Research Electronic Data Capture).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Otherwise healthy 3-10 years old children referred to tympanostomy tube insertion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Finnish speaking (child and parent)\n\nExclusion Criteria:\n\n* Prior sensorineural hearing loss\n* developmental disorder\n* Prior ear surgery (except tympanostomy insertion)'}, 'identificationModule': {'nctId': 'NCT05535634', 'briefTitle': 'Sound Ear Check (SEC) in Hearing Diagnostics in Young Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Sound Ear Check (SEC) in Hearing Diagnostics in Young Children Undergoing Tympanostomy Tube Insertion', 'orgStudyIdInfo': {'id': 'T9/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children referred for tympanostomy tube insertion', 'description': 'Study Sound Ear Check (SEC) hearing test among 3-10 years old otherwise healthy children referred to tympanostomy tube placement. SEC test prior surgery (with middle ear fluid) and at 1 month control visit (dry middle ear with ventilation tube). Otitis media 6 questionnaire prior surgery and at the 1 month control visit.', 'interventionNames': ['Diagnostic Test: Sound Ear Check']}], 'interventions': [{'name': 'Sound Ear Check', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Tympanometry'], 'description': 'Hearing test, measurement of the input impedance of the middle-ear transmission system', 'armGroupLabels': ['Children referred for tympanostomy tube insertion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Turku', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Lotta Haavisto, PhD', 'role': 'CONTACT', 'email': 'lotta.haavisto@tyks.fi', 'phone': '+35823130000'}, {'name': 'Vesa Lahdes, M.D.', 'role': 'CONTACT', 'email': 'vesa.lahdes@tyks.fi', 'phone': '+35823130000'}, {'name': 'Tytti Willberg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vesa Lahdes, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tuomo Puhakka, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Turku University Hospital, Department of Otorhinolaryngology and head and neck surgery', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'centralContacts': [{'name': 'Lotta Haavisto, PhD', 'role': 'CONTACT', 'email': 'lotta.haavisto@tyks.fi', 'phone': '+358 23130000'}, {'name': 'Vesa Lahdes, M.D.', 'role': 'CONTACT', 'email': 'vesa.lahdes@tyks.fi', 'phone': '+358 23130000'}], 'overallOfficials': [{'name': 'Lotta Haavisto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital District of Southwest Finland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vesa Lahdes', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Vesa Lahdes', 'investigatorAffiliation': 'Turku University Hospital'}}}}