Validation of Cognitive Screenings for the Hearing Impaired

NCT ID: NCT03648502

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-09

Study Completion Date

2020-03-13

Brief Summary

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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.

Cognitive 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.

Detailed Description

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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.

Communication 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).

Therefore, 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.

Moreover, 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.

In 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.

Conditions

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Dementia Hearing Loss Auditory Processing Disorder

Keywords

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dementia hearing loss auditory process

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

3 participants arms Diagnostic tools validation
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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dementia (D-HI)

hearing impaired dementia

Group Type EXPERIMENTAL

Cognitive tests and hearing tests

Intervention Type DIAGNOSTIC_TEST

Several cognitive and hearing (peripheral and (central) auditory process) tests

Mild cognitive impairment (MCI-HI)

MCI with hearing loss

Group Type OTHER

Cognitive tests and hearing tests

Intervention Type DIAGNOSTIC_TEST

Several cognitive and hearing (peripheral and (central) auditory process) tests

normal (N-HI)

normal cognition with hearing loss

Group Type ACTIVE_COMPARATOR

Cognitive tests and hearing tests

Intervention Type DIAGNOSTIC_TEST

Several cognitive and hearing (peripheral and (central) auditory process) tests

Interventions

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Cognitive tests and hearing tests

Several cognitive and hearing (peripheral and (central) auditory process) tests

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age over 65 years
* Documented Hearing loss (currently wearing hearing aids and/or hearing testing with a hearing average of \>/= 30dB HL in D-HI,MCI-HI group)

Exclusion Criteria

* 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.
* Severe to profound hearing loss (PTA \>70dBHL)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nattawan Utoomprurkporn, MD,Msc

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

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Royal National Throat Nose Ear Hospital

London, , United Kingdom

Site Status

Camden and Islington NHS memory service

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 22434018 (View on PubMed)

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.

Reference Type RESULT
PMID: 23337978 (View on PubMed)

Other Identifiers

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18/0306

Identifier Type: -

Identifier Source: org_study_id