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Validation of Cognitive Screenings for the Hearing Impaired

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ClinicalTrials.gov Identifier: NCT03648502
Recruitment Status : Suspended (The corona virus pandemic)
First Posted : August 27, 2018
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dementia Hearing Loss Auditory Processing Disorder Diagnostic Test: Cognitive tests and hearing tests Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 participants arms Diagnostic tools validation
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Validation of "Montreal Cognitive Assessment (MoCA) and Addenbrooke's Cognitive Examination III (ACE-III) "as a Cognitive Screening Tools for the Hearing Impaired
Actual Study Start Date : November 9, 2018
Actual Primary Completion Date : March 13, 2020
Estimated Study Completion Date : September 13, 2021

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648502


Locations
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United Kingdom
Royal National Throat Nose Ear Hospital
London, United Kingdom, WC1X 8DA
Camden and Islington NHS memory service
London, United Kingdom
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Nattawan Utoomprurkporn, MD,Msc University College, London

Publications of Results:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03648502    
Other Study ID Numbers: 18/0306
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: only share within researchers team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
dementia
hearing loss
auditory process
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Auditory Perceptual Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms
Auditory Diseases, Central
Retrocochlear Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Cognition Disorders