Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT04162405
Status:
UNKNOWN
Last Update Posted:
2019-11-20
First Post:
2019-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tinnitus in Patients With and Without Sensorineural Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}, {'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-18', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2019-11-11', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Establishing correlations between DPOAE, TA, and THI values', 'timeFrame': '2 hours', 'description': 'Evaluating whethere there are certain characteristics of tinnitus correlated with patients with and without hearing loss'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tinnitus', 'sensorineural hearing loss', 'otoacoustic emission', 'normacusis', 'questionnaire'], 'conditions': ['Tinnitus, Subjective', 'Hearing Loss', 'Otorhinolaryngologic Diseases']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate hearing characteristics in patients with and without tinnitus using DPOAE and specific tinnitus severity index (TSI) and tinnitus handicap inventory (THI) questionnaires in both groups.\n\nPurpose of the research:\n\nDemonstrate that the characteristics of tinnitus depend on the presence and magnitude of hearing loss.\n\nResearch participants:\n\n150 patients coming for further audiological treatment due to tinnitus. Data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be performed.', 'detailedDescription': 'Tinnitus affects 17% of the total population and as many as 33% of the elderly and is the primary symptom in 60% of patients referred for audiological treatment. Tinnitus is the perception of sound without external stimuli. Its pathophysiological basis is unknown and therefore its treatment is difficult and understanding of other disorders that occur in the auditory system is impeded. The auditory system has a complex structure that consists of the organs of Corti, the afferent and efferent conduction pathways, the cortical auditory center and the connections that allow their integration. The pathology that develops in any of these parts leads to a heightened perception of sound by unknown mechanisms. Patients can describe tinnitus in a variety of ways, such as sea noise, rapid flow, ringing, howling and whistling. The measurement of otoacoustic emissions by distortion products (DPOAE) is the main method that allows the evaluation of the mechanical activity of the cochlea in patients with tinnitus. In these patients, hyperacusis plays an important role and it can often be a precursor to tinnitus. The aim of this study is to evaluate hearing characteristics in patients with and without tinnitus using DPOAE and specific tinnitus severity index (TSI) and tinnitus handicap inventory (THI) questionnaires in both groups.\n\nResearch goal:\n\nIdentify differences in tinnitus characteristics in patients with and without significant hearing impairment.\n\nPurpose of the research:\n\nDemonstrate that the characteristics of tinnitus depend on the presence and magnitude of the visual hearing impairment.\n\nResearch participants:\n\n150 patients coming for further audiological treatment due to tinnitus. The data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be made.\n\nResearch plan:\n\nA prospective cohort nonrandomized study of non-masked parallel paired groups. When receiving patients at the Hearing and Balance Center, the inclusion criteria for admission to the study are adulthood (\\> 18 years), tinnitus as the primary reason for referring to diagnostic treatment, and consent to complete two on-site tinnitus questionnaires. Exclusion criteria are conductive hearing impairment and incomplete questionnaires. It is planned to evaluate the differences in tinnitus character between groups of patients with and without significant hearing impairment with respect to the objective parameters of the audiogram and DPAOE.\n\nPrimary Outcome:\n\nIdentification of key differences in subjective and objective characteristics of tinnitus in patients with and without noticeable hearing impairment.\n\nThere is no risk involved in this research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with and without hearing loss suffering from tinnitus, scheduled for diagnostic in a tertiary audiological center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adulthood (\\> 18 years), tinnitus as the primary reason for referring to diagnostic processing, and consent to complete two on-site tinnitus questionnaires\n\nExclusion Criteria:\n\n* conductive hearing loss and incomplete questionnaires'}, 'identificationModule': {'nctId': 'NCT04162405', 'briefTitle': 'Tinnitus in Patients With and Without Sensorineural Hearing Loss', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Sestre Milosrdnice'}, 'officialTitle': 'Characteristics of Tinnitus in Patients With and Without Sensorineural Hearing Loss: A Matched Pair Analysis', 'orgStudyIdInfo': {'id': 'EP-TINN01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with tinnitus and hearing loss', 'description': 'Patients with tinnitus and average speech-frequency tonal audiogram threshold \\>30 dB', 'interventionNames': ['Behavioral: Tinnitus Handicap Inventory Test']}, {'label': 'Patients with tinnitus without hearing loss', 'description': 'Patients with tinnitus and average speech-frequency tonal audiogram threshold \\<30 dB', 'interventionNames': ['Behavioral: Tinnitus Handicap Inventory Test']}], 'interventions': [{'name': 'Tinnitus Handicap Inventory Test', 'type': 'BEHAVIORAL', 'otherNames': ['Distortion Product Otoacoustic Emission'], 'description': 'A prospective cohort nonrandomized study of non-masked parallel paired groups. The data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be performed.', 'armGroupLabels': ['Patients with tinnitus and hearing loss', 'Patients with tinnitus without hearing loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Andro Košec, MD, PhD', 'role': 'CONTACT', 'email': 'andro.kosec@yahoo.com', 'phone': '+385989817156'}, {'name': 'Mihael Ries, MD, PhD', 'role': 'CONTACT', 'email': 'miskories@gmail.com', 'phone': '+385989817156'}], 'facility': 'University Hospital Center Sestre milosrdnice', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'centralContacts': [{'name': 'Andro Košec, MD, PhD', 'role': 'CONTACT', 'email': 'andro.kosec@yahoo.com', 'phone': '+385989817156'}, {'name': 'Mihael Ries, MD, PhD', 'role': 'CONTACT', 'email': 'miskories@gmail.com', 'phone': '+38513787430'}], 'overallOfficials': [{'name': 'Robert Trotić, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Sestre Milosrdnice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Otorhinolaryngologist and Head and Neck Surgeon', 'investigatorFullName': 'Andro Košec, MD, PhD', 'investigatorAffiliation': 'University Hospital Sestre Milosrdnice'}}}}