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Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment

Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06400173
Acronym
MoCA-HI
Enrollment
450
Registered
2024-05-06
Start date
2023-09-01
Completion date
2025-12-31
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Hearing Loss

Keywords

Cognitive screening, Montreal Cognitive Assessment

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.

Interventions

The Dutch Montreal Cognitive Assessment for persons with hearing loss (MoCA-HI) is a modified version of the original MoCA test specifically designed for individuals with hearing loss. It includes adaptations such as visual aids to accommodate for hearing loss, ensuring fair assessment of cognitive abilities in this population.

Four audiological tests are included in the audiological assessment 1. Tympanometry to assss the middle ear status 2. Pure-tone audiometry with headphone to evaluate the hearing thresholds 3. Speech audiometry in free field to assess the ability to understand spoken words in the presence of background noise 4. The hAVICOP questionnaire to assess the hearing-related quality of life

Sponsors

University Hospital, Ghent
CollaboratorOTHER
University Ghent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Hearing statusThis parameter will be assessed once during the first study visit of the patient. Test duration is approximately 20 minutes.Based on the results of the tympanometry and pure-tone audiometry the hearing status of the participant will be classified as normal or abnormal. In case of abnormal hearing, the type and severity will be specified.
MoCA-HIThis 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.The result (max 30) on the MoCA-HI will be calculated.
Hearing-related quality of lifeThis parameter will be assessed once during the first study visit of the patient. Test duration is approximately 15 minutes.Mean scores will be calculated for each subdomain separately (auditory-visual, cognitive, and psychosocial functioning) as well as combined within a total score. The scores can range from 0 to 100 whereby the worse one's hearing-related quality of life, the lower the score.

Countries

Belgium

Contacts

Primary ContactKatrien Kestens, PhD
katrien.kestens@ugent.be003293320865
Backup ContactTim Van Langenhove, MD, PhD
tim.vanlangenhove@uzgent.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026