Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-02-01 @ 5:29 PM
Study NCT ID:
NCT01837368
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2012-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2012-12-19', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Values of PRISM', 'timeFrame': '4 weeks', 'description': 'measures the burden of suffering'}, {'measure': 'TAS', 'timeFrame': '4 weeks', 'description': 'Alexithymia- measured with TAS-toronto alexithymia scale; measures ability to identify feelings, describe feeling, and style of thinking'}], 'secondaryOutcomes': [{'measure': 'Quality of life (SF-36), perceived grade of tinnitus (THI, TF, TBF-12) and the clinical characteristic of tinnitus.', 'timeFrame': '4 weeks', 'description': 'composite outcome'}, {'measure': 'comorbidities', 'timeFrame': '4 weeks', 'description': 'measured with BAI , BDI'}, {'measure': 'Tinnitus functional index (TFI) perceived grade of tinnitus', 'timeFrame': '4 weeks', 'description': 'Composite outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tinnitus']}, 'referencesModule': {'references': [{'pmid': '28476163', 'type': 'DERIVED', 'citation': 'Peter N, Kleinjung T, Jeker R, Meyer M, Klaghofer R, Weidt S. Tinnitus functional index: validation of the German version for Switzerland. Health Qual Life Outcomes. 2017 May 5;15(1):94. doi: 10.1186/s12955-017-0669-x.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=PRISM+Tinnitus', 'label': 'Publication Tinnitus and PRISM'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/26850646', 'label': 'Publication Tinnitus and quality of life'}]}, 'descriptionModule': {'briefSummary': 'Validation of PRISM (Pictorial Representation of Illness and Self Measure) as a assessment of quality of life and suffering in patients with tinnitus.\n\nAssociation between experiencing, verbalizing and regulating emotions and perceived tinnitus.\n\nCorrelation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective EEG-patterns.', 'detailedDescription': 'Validation of PRISM (Pictorial Representation of Illness and Self Measure). Assessment of quality of life and suffering in patients with tinnitus in an observational study using different questionnaires. (THI, TF, TBF-12, BDI, BAI, SF-36).\n\nTHI - Tinnitus Handicap Inventory\n\nTF - Tinnitus Questionnaire after Goebel and Hiller\n\nTBF-12 - Tinnitus Impairment Questionnaire\n\nBDI - Beck Depression Inventory\n\nBAI - Beck Anxiety Inventory\n\nSF-36 - Short Form 36 Health Survey Questionnaire\n\nAssociation between experiencing, verbalizing and regulating emotions and perceived tinnitus using the TAS-20 (20-Item Toronto Alexithymia Scale) and the above mentioned questionnaires.\n\nEEG-studies on the spontaneous brain activity of individuals affected by tinnitus consistently report differences in the composition of the EEG-frequency spectrum between individuals with tinnitus and healthy controls. Furthermore it has been shown that not only the auditory cortex but other regions of the brain are involved in the perception of the chronic ear noise as well. Among them is the limbic system which is associated with the emotional processing of the human brain.\n\nCorrelation analysis are used to search for connections between the subjective behavioral outcomes mentioned above and the objective EEG-patterns. Aim of the current study is to provide conclusive models of associated assessments of the psychological strain end emotional stress of individuals suffering from tinnitus and objective EEG-analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with tinnitus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* all patients older than 18 years with tinnitus who want to participate the investigation during the period of data acquisition\n\nExclusion criteria:\n\n* patients younger than 18 years,\n* insufficient knowledge of the German language.'}, 'identificationModule': {'nctId': 'NCT01837368', 'briefTitle': 'Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Research Project About Psychological Strain, Quality of Life and Emotional Awareness in Patients With Tinnitus', 'orgStudyIdInfo': {'id': 'tinnitus_T0'}}, 'armsInterventionsModule': {'interventions': [{'name': 'observational research', 'type': 'OTHER', 'description': 'It is a observational research, no intervention are performed'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Psychiatry and Psychotherapy', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Steffi Weidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Psychiatry and Psychotherapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}