Clinical trial NCT03648502: 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
Overall status: TERMINATED
Phase: NA
Conditions: Dementia
Hearing Loss
Auditory Processing Disorder
Keywords: dementia
hearing loss
auditory process
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 78
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 participants arms Diagnostic tools validation
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: The adapted version Montreal Cognitive Assessment (MoCA) questionnaire total score among dementia/mild cognitive impairment/normal cognition group of hearing impaired older adult.
timeFrame: approximately 1 years (expected to recruit 30 participants for each group)
measure: 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.
timeFrame: approximately 1 years (expected to recruit 30 participants for each group)
Secondary outcomes:
measure: 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)
timeFrame: approximately 1 years (expected to recruit 30 participants for each group)
Other outcomes:
measure: 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.
timeFrame: 1 year follow up from initial recruitment
Locations:
city: London
country: United Kingdom
facility: Royal National Throat Nose Ear Hospital
city: London
country: United Kingdom
facility: Camden and Islington NHS memory service
Study officials:
affiliation: University College, London
name: Nattawan Utoomprurkporn, MD,Msc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.