Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01395368
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2011-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cognitive Speed as an Objective Measure of Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'piccirilloj@ent.wustl.edu', 'phone': '314 362-8641', 'title': 'Dr. Jay F. Piccirillo, Professor', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Tinnitus subjects with moderate or greater depression were excluded from the study. This study may not be reflective of the population of bothersome tinnitus patients due to this exclusion'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tinnitus', 'description': "Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.", 'otherNumAtRisk': 92, 'otherNumAffected': 0, 'seriousNumAtRisk': 92, 'seriousNumAffected': 0}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brain Speed Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tinnitus', 'description': "Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'groupId': 'OG000', 'lowerLimit': '-0.23', 'upperLimit': '0.05'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants completed brain speed test on the same day as enrollment. No follow-up required.', 'description': 'Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations.', 'unitOfMeasure': 'z-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who completed the study with the exception of 4 subjects whose data was excluded due to the fact that they were younger than the the normative age-specific data available and BST Z-scores were not able to be calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tinnitus', 'description': "Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "Participants were recruited from Washington University's Volunteer for Health office, the audiology division and the otolaryngology faculty clinical practices at Washington University Department of Otolaryngology-Head and Neck Surgery, including the PI's population of tinnitus patients."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tinnitus', 'description': "Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2011-07-13', 'resultsFirstSubmitDate': '2012-04-13', 'studyFirstSubmitQcDate': '2011-07-14', 'lastUpdatePostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-18', 'studyFirstPostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Speed Test', 'timeFrame': 'Participants completed brain speed test on the same day as enrollment. No follow-up required.', 'description': 'Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['subjective', 'unilateral', 'bilateral', 'non-pulsatile', "6 month's duration or longer"], 'conditions': ['Tinnitus']}, 'descriptionModule': {'briefSummary': 'Tinnitus, commonly referred to as "ringing in the ears", affects 50 million people in the United States and is recognized as a major public health concern. Tinnitus is the most frequent cause of service-connected disability claims among war veterans. Tinnitus remains a subjectively diagnosed entity. There is no standardized objective method of diagnosing tinnitus or describing the functional impact of the condition. Currently, physicians have to rely on patient-based self reports. Without an objective method of diagnosing tinnitus and describing the functional implications, adequate treatment delivery is also hampered since there is no way to objectively stratify patients into severity groups and assess response to treatment. Because tinnitus is known to negatively affect cognition through the ventral attention networks and the prefrontal cortex, measuring cognitive processing speed is a possible way to objectively measure tinnitus. This study builds on previous work the investigators have done that utilized a quick, easily accessible measure of auditory processing speed. That earlier study showed a correlation between that measure and self reported measures of tinnitus severity, and this study attempts determine a more precise estimate of that correlation. It also better validates those results by including a traditional neurocognitive measuring cognitive speed and by controlling for the presence of depression and somatoform disorders.', 'detailedDescription': 'This was a cross-sectional study designed to investigate the relationship that self-reported tinnitus severity has with cognitive processing speed and psychiatric factors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population will include men and women between the ages of 18-80 years who have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be between the ages of 18 and 80.\n* Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month\'s duration or longer.\n* Participants must be able to read, write and speak using the English language.\n* Participants must be able to read and follow the instructions for both computerized tests, "The Brain Speed Test" and "The 60 Second Brain Game."\n* Participants must be able to provide written informed consent.\n\nExclusion Criteria:\n\n* Participants with tinnitus related to Workman\'s Compensation Claim or other litigation-related situations.\n* Participants with active diagnoses of any acute or chronic brain-related neurological conditions that alter normal brain anatomy or function including Parkinson\'s disease, Multiple Sclerosis, Alzheimer\'s Disease, cerebral infarcts, traumatic brain injury, history of brain tumor(s), epilepsy, or dementia.\n* Participants with tinnitus related to retrocochlear lesions, cochlear implants, or other known anatomic/structural lesions of the brain, skull-base, temporal bone or ear.\n* Participants who have a hearing threshold above 90 dB on any of the tested frequencies during audiometry.\n* Participants unable to hear the highest volume of the computer-based objective assessments.\n* Participants taking any medications that may affect or alter cognition including but not limited to sedatives, hypnotics, narcotics, or opiates.\n* Participants with any medical condition the PI determines would compromise the safety of the participant or complicate the interpretation of the study results.'}, 'identificationModule': {'nctId': 'NCT01395368', 'acronym': 'COMeT', 'briefTitle': 'Cognitive Speed as an Objective Measure of Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Cognitive Speed as an Objective Measure of Tinnitus', 'orgStudyIdInfo': {'id': '201103191'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Brain Speed Test', 'description': 'Brain Speed Test'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Jay F Piccirillo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Washington University School of Medicine', 'investigatorFullName': 'Jay F. Piccirillo, MD', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}