Clinical trial NCT06400173: Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment
Official title: Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Hearing Loss
Keywords: Cognitive screening
Montreal Cognitive Assessment
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2024-05-06
Enrollment: 450
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with cognitive impairment and/or hearing loss

Brief summary: The Montreal Cognitive Assessment (MoCA) is a screening test for detecting cognitive impairment that assesses several cognitive domains (attention and concentration, arithmetic and orientation, memory, etc.). The instructions as well as some test items of the MoCA are presented auditory (spoken). Consequently, performance on the MoCA may be co-dependent on hearing. Therefore, to rule out the possible negative influence of hearing loss on performance on the MoCA, a MoCA for individuals with hearing loss was recently developed. More specifically, the original MoCA was modified by providing the instructions audiovisually (spoken with visual support) as well as by replacing hearing-dependent items. Since replacing items may affect sensitivity and specificity, the MoCA for persons with hearing loss should be revalidated.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 60 years or older
* Individuals with normal vision (with lenses or glasses if needed)
* Individuals with age-related hearing loss
* Dutch-speaking individuals
* Individuals capable of giving consent to participate in the study themselves
* Individuals still residing in their own homes
* Individuals with an official diagnosis of dementia (Alzheimer's, vascular, or mixed) or mild cognitive impairment. This inclusion criterion applies only to the group with cognitive impairment.

Exclusion Criteria:

For individuals without cognitive impairment, the following exclusion criteria apply:

* (History of) neurological problems (brain tumor, epilepsy, history of stroke, etc.)
* Use of influencing medication (e.g., Ritalin and antidepressants)

Primary outcomes:
measure: Hearing status
timeFrame: This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 20 minutes.
measure: MoCA-HI
timeFrame: This parameter will be assessed once (during the first study visit) or twice (during the second study visit 4 weeks later), depending on the random selection for the test-retest group. Test duration is approximately 15 minutes.
measure: Hearing-related quality of life
timeFrame: This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 15 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent Hospital
state: East-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Tim Van Langenhove, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: