Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-21 @ 8:01 AM
Study NCT ID:
NCT03648502
Status:
TERMINATED
Last Update Posted:
2020-11-09
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Cognitive Screenings for the Hearing Impaired
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D001308', 'term': 'Auditory Perceptual Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001304', 'term': 'Auditory Diseases, Central'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006320', 'term': 'Hearing Tests'}], 'ancestors': [{'id': 'D003939', 'term': 'Diagnostic Techniques, Otological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 participants arms Diagnostic tools validation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'whyStopped': 'The corona virus pandemic\\_UK national lockdown', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-05', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Final cognitive status diagnosis (base on ICD-10 coding system; dichotomous outcome; code F00-F03 (dementia) or code ICD F06.7 (Mild cognitive impairment)) provided by an NHS memory service doctors at routine clinical care follow up session at 1 year.', 'timeFrame': '1 year follow up from initial recruitment', 'description': 'The final cognitive status diagnosis of the population will be compared with hearing and cognitive outcome measures at baseline ie. the hearing threshold from audiogram (in dB HL)) and MoCA and ACE-III tests score and mAIAD questionnaire scores to determine what parameters best predict cognitive change in diagnosis from the baseline assessments in hearing impaired/cognitive impaired population.'}], 'primaryOutcomes': [{'measure': 'The adapted version Montreal Cognitive Assessment (MoCA) questionnaire total score among dementia/mild cognitive impairment/normal cognition group of hearing impaired older adult.', 'timeFrame': 'approximately 1 years (expected to recruit 30 participants for each group)', 'description': 'The score will be used to calculate the appropriate cut-point score for differentiating each group of hearing impaired older adults.(total score ranging from 0-30 points with higher score indicate better cognitive function)'}, {'measure': "The adapted version Addenbrooke's Cognitive Examination III (ACE-III) questionnaire total score among dementia/mild cognitive impairment/normal cognition group of hearing impaired older adult.", 'timeFrame': 'approximately 1 years (expected to recruit 30 participants for each group)', 'description': 'The score will be used to calculate the appropriate cut-point score for differentiating each group of hearing impaired older adults (total score ranging from 0-100 points with higher score indicate better cognitive function)'}], 'secondaryOutcomes': [{'measure': 'Hearing handicap score from the Modified Amsterdam Inventory for Auditory Disability and Handicap (mAIAD) (total score ranging from 0-84 with higher score indicate smaller perceived hearing difficulty)', 'timeFrame': 'approximately 1 years (expected to recruit 30 participants for each group)', 'description': 'The score from mAIAD and the hearing threshold from audiogram (in dB HL) along with the MoCA and ACE-III test scores will be used to determine what best predicts hearing handicap in the cognitively impaired population.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia', 'hearing loss', 'auditory process'], 'conditions': ['Dementia', 'Hearing Loss', 'Auditory Processing Disorder']}, 'referencesModule': {'references': [{'pmid': '22434018', 'type': 'RESULT', 'citation': 'MacDonald AA, Joyson A, Lee R, Seymour DG, Soiza RL. The effect of hearing augmentation on cognitive assessment scales at admission to hospital. Am J Geriatr Psychiatry. 2012 Apr;20(4):355-61. doi: 10.1097/JGP.0b013e3182107e88.'}, {'pmid': '23337978', 'type': 'RESULT', 'citation': 'Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E, Satterfield S, Ayonayon HN, Ferrucci L, Simonsick EM; Health ABC Study Group. Hearing loss and cognitive decline in older adults. JAMA Intern Med. 2013 Feb 25;173(4):293-9. doi: 10.1001/jamainternmed.2013.1868.'}]}, 'descriptionModule': {'briefSummary': 'There are currently no cognitive tests that have been validated as screening tools for people with dementia and comorbid hearing loss. This is particularly important given the high prevalence of hearing impairment in older adults presenting to memory services and the risk of misdiagnosis of dementia in this population as outlined above.\n\nCognitive tests validated in hearing impaired populations will also be important as outcome tools for interventional research aiming to find out if treating hearing loss may reduce dementia risk in the longer term.', 'detailedDescription': "Hearing loss is very prevalent in older population. This leads to further problems such as communication problem, isolation from the community and depression. Moreover, hearing impairment may potentially affect the patients' cognitive function as demonstrated in the above mentioned published papers.\n\nCommunication problems that arise from a hearing loss alone can also interfere with administration of cognitive test battery, as a previous study showed that re-administered of MMSE test with assistive listening device can immediately improve the test score among elderly (1).\n\nTherefore, special adaptation of the cognitive test battery to address the needs of hearing impaired older adult is necessary. This is to ensure that the test result reflects the exact cognitive state of the older adult with hearing impairment, not effected by hearing loss.\n\nMoreover, appropriate cut-off point scores for hearing impaired population should be identified for these new cognitive screening tools. This is to ensure appropriate referral for further diagnosis and prompt management for cognitive impairment/dementia among older adults with hearing loss.\n\nIn addition, since hearing loss can potentially lead to deterioration in patients' cognitive function over time (2). Follow up assessments of cognitive function among older adults with hearing impairment can determine the rate of deterioration in retrospective trial(2). This prospective trial follow up of cognitive function among hearing loss participants may uncover additional risk factors associated with the deterioration. Better understanding of these risk factors can potentially lead to further intervention in order to delay decline in patients' cognitive function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 65 years\n* Documented Hearing loss (currently wearing hearing aids and/or hearing testing with a hearing average of \\>/= 30dB HL in D-HI,MCI-HI group)\n\nExclusion criteria\n\n* Uncorrected visual impairment; cognitive and/or physical disability(s) which prevent the performance of the written/drawing elements of the tests, in the opinion of the researcher.\n* Severe to profound hearing loss (PTA \\>70dBHL)'}, 'identificationModule': {'nctId': 'NCT03648502', 'briefTitle': 'Validation of Cognitive Screenings for the Hearing Impaired', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Validation of "Montreal Cognitive Assessment (MoCA) and Addenbrooke\'s Cognitive Examination III (ACE-III) "as a Cognitive Screening Tools for the Hearing Impaired', 'orgStudyIdInfo': {'id': '18/0306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dementia (D-HI)', 'description': 'hearing impaired dementia', 'interventionNames': ['Diagnostic Test: Cognitive tests and hearing tests']}, {'type': 'OTHER', 'label': 'Mild cognitive impairment (MCI-HI)', 'description': 'MCI with hearing loss', 'interventionNames': ['Diagnostic Test: Cognitive tests and hearing tests']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'normal (N-HI)', 'description': 'normal cognition with hearing loss', 'interventionNames': ['Diagnostic Test: Cognitive tests and hearing tests']}], 'interventions': [{'name': 'Cognitive tests and hearing tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'Several cognitive and hearing (peripheral and (central) auditory process) tests', 'armGroupLabels': ['Mild cognitive impairment (MCI-HI)', 'dementia (D-HI)', 'normal (N-HI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1X 8DA', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal National Throat Nose Ear Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Camden and Islington NHS memory service', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nattawan Utoomprurkporn, MD,Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'only share within researchers team'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}