DementiaNCT03648502
Validation of Cognitive Screenings for the Hearing Impaired
A study testing Cognitive tests and hearing tests in people with Dementia and Hearing Loss, run by University College, London at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Hearing Loss, Auditory Processing Disorder
- What is being tested?
- Cognitive tests and hearing tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 9 Nov 2018to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal National Throat Nose Ear Hospital
London, WC1X 8DA
Camden and Islington NHS memory service
London
About this study
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
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.
Read the 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.
- Conditions
- Dementia, Hearing Loss, Auditory Processing Disorder
- Being tested
- Cognitive tests and hearing tests
- Keywords
- dementia, hearing loss, auditory process
- Medical subject headings
- Dementia, Hearing Loss, Auditory Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive tests and hearing testsDiagnostic test
Several cognitive and hearing (peripheral and (central) auditory process) tests
| Study group | Role | What they receive |
|---|---|---|
| dementia (D-HI) | Experimental | hearing impaired dementia Receives: Diagnostic Test: Cognitive tests and hearing tests |
| Mild cognitive impairment (MCI-HI) | Other | MCI with hearing loss Receives: Diagnostic Test: Cognitive tests and hearing tests |
| normal (N-HI) | Active comparator | normal cognition with hearing loss Receives: Diagnostic Test: Cognitive tests and hearing tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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)
Measured: approximately 1 years (expected to recruit 30 participants for each group)
Secondary outcomes (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)
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.
Measured: approximately 1 years (expected to recruit 30 participants for each group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start9 Nov 2018
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: The corona virus pandemic\_UK national lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 participants arms Diagnostic tools validation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nattawan Utoomprurkporn, MD,Msc, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648502
- Sponsor's protocol ID
- 18/0306
- Status last verified
- Nov 2020
- First submitted
- 2 Aug 2018
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only share within researchers team
Publications
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.
PubMed 22434018Lin 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.
PubMed 23337978
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03648502
- Acronym / sponsor ID
- 18/0306
- Conditions
- Dementia, Hearing Loss, Auditory Processing Disorder
- Keywords
- dementia, hearing loss, auditory process
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The corona virus pandemic\_UK national lockdown
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 participants arms Diagnostic tools validation
| Arm | Type | Receives |
|---|---|---|
| dementia (D-HI) | Experimental | Diagnostic Test: Cognitive tests and hearing testshearing impaired dementia |
| Mild cognitive impairment (MCI-HI) | Other | Diagnostic Test: Cognitive tests and hearing testsMCI with hearing loss |
| normal (N-HI) | Active comparator | Diagnostic Test: Cognitive tests and hearing testsnormal cognition with hearing loss |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive tests and hearing testsSeveral cognitive and hearing (peripheral and (central) auditory process) tests | Diagnostic test | Mild cognitive impairment (MCI-HI), dementia (D-HI), normal (N-HI) |
Primary outcome
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)
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)
1 secondary outcome
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)
Results and safety
The study was stopped early (reason given: The corona virus pandemic\_UK national lockdown). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Results publication: PubMed 22434018MacDonald 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 publication: PubMed 23337978Lin 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.
- Individual participant dataSharing planned: No. only share within researchers team
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nattawan Utoomprurkporn, MD,Msc principal investigator
University College, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive tests and hearing tests in people with Dementia and Hearing Loss, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The corona virus pandemic\_UK national lockdown). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03648502, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.