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Validation of Cognitive Screenings for the Hearing Impaired

Primary Purpose

Dementia, Hearing Loss, Auditory Processing Disorder

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive tests and hearing tests
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dementia focused on measuring dementia, hearing loss, auditory process

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Royal National Throat Nose Ear Hospital
  • Camden and Islington NHS memory service

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Active Comparator

Arm Label

dementia (D-HI)

Mild cognitive impairment (MCI-HI)

normal (N-HI)

Arm Description

hearing impaired dementia

MCI with hearing loss

normal cognition with hearing loss

Outcomes

Primary Outcome Measures

The adapted version Montreal Cognitive Assessment (MoCA) questionnaire total score among dementia/mild cognitive impairment/normal cognition group of hearing impaired older adult.
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)
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.
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

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)
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.

Full Information

First Posted
August 2, 2018
Last Updated
November 5, 2020
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03648502
Brief Title
Validation of Cognitive Screenings for the Hearing Impaired
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
The corona virus pandemic_UK national lockdown
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Hearing Loss, Auditory Processing Disorder
Keywords
dementia, hearing loss, auditory process

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 participants arms Diagnostic tools validation
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dementia (D-HI)
Arm Type
Experimental
Arm Description
hearing impaired dementia
Arm Title
Mild cognitive impairment (MCI-HI)
Arm Type
Other
Arm Description
MCI with hearing loss
Arm Title
normal (N-HI)
Arm Type
Active Comparator
Arm Description
normal cognition with hearing loss
Intervention Type
Diagnostic Test
Intervention Name(s)
Cognitive tests and hearing tests
Intervention Description
Several cognitive and hearing (peripheral and (central) auditory process) tests
Primary Outcome Measure Information:
Title
The adapted version Montreal Cognitive Assessment (MoCA) questionnaire total score among dementia/mild cognitive impairment/normal cognition group of hearing impaired older adult.
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)
Time Frame
approximately 1 years (expected to recruit 30 participants for each group)
Title
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.
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)
Time Frame
approximately 1 years (expected to recruit 30 participants for each group)
Secondary Outcome Measure Information:
Title
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)
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.
Time Frame
approximately 1 years (expected to recruit 30 participants for each group)
Other Pre-specified Outcome Measures:
Title
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.
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.
Time Frame
1 year follow up from initial recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nattawan Utoomprurkporn, MD,Msc
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal National Throat Nose Ear Hospital
City
London
ZIP/Postal Code
WC1X 8DA
Country
United Kingdom
Facility Name
Camden and Islington NHS memory service
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
only share within researchers team
Citations:
PubMed Identifier
22434018
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.
Results Reference
result
PubMed Identifier
23337978
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.
Results Reference
result

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Validation of Cognitive Screenings for the Hearing Impaired

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