Validation of Cognitive Screenings for the Hearing Impaired

November 5, 2020 updated by: University College, London

Validation of "Montreal Cognitive Assessment (MoCA) and Addenbrooke's Cognitive Examination III (ACE-III) "as a Cognitive Screening Tools for the Hearing Impaired

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1X 8DA
        • Royal National Throat Nose Ear Hospital
      • London, United Kingdom
        • Camden and Islington NHS memory service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dementia (D-HI)
hearing impaired dementia
Diagnostic test: Cognitive tests and hearing tests
Several cognitive and hearing (peripheral and (central) auditory process) tests
Other: Mild cognitive impairment (MCI-HI)
MCI with hearing loss
Diagnostic test: Cognitive tests and hearing tests
Several cognitive and hearing (peripheral and (central) auditory process) tests
Active Comparator: normal (N-HI)
normal cognition with hearing loss
Diagnostic test: Cognitive tests and hearing tests
Several cognitive and hearing (peripheral and (central) auditory process) tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The adapted version Montreal Cognitive Assessment (MoCA) questionnaire total score among dementia/mild cognitive impairment/normal cognition group of hearing impaired older adult.
Time Frame: approximately 1 years (expected to recruit 30 participants for each group)
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)
approximately 1 years (expected to recruit 30 participants for each group)
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.
Time Frame: approximately 1 years (expected to recruit 30 participants for each group)
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)
approximately 1 years (expected to recruit 30 participants for each group)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: approximately 1 years (expected to recruit 30 participants for each group)
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.
approximately 1 years (expected to recruit 30 participants for each group)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 year follow up from initial recruitment
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.
1 year follow up from initial recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Nattawan Utoomprurkporn, MD,Msc, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2018

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18/0306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

only share within researchers team

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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