Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment
MoCA-HI
1 other identifier
observational
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 12, 2024
CompletedFirst Posted
Study publicly available on registry
May 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMay 6, 2024
May 1, 2024
2.3 years
April 12, 2024
May 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Hearing status
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.
This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 20 minutes.
MoCA-HI
The result (max 30) on the MoCA-HI will be calculated.
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.
Hearing-related quality of life
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.
This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 15 minutes.
Study Arms (3)
Individuals (>45 years) with mild cognitive impairment and hearing loss
All tests will be administered.
Individuals (>45 years) with dementia (Alzheimer, vascular or mixed) and hearing loss
All tests will be administered.
Individuals (>45 years) with age-normal cognition and hearing loss
All tests will be administered.
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
Eligibility Criteria
Individuals with cognitive impairment and/or hearing loss
You may qualify if:
- 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
You may not qualify if:
- (History of) neurological problems (brain tumor, epilepsy, history of stroke, etc.)
- Use of influencing medication (e.g., Ritalin and antidepressants)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
- University Hospital, Ghentcollaborator
Study Sites (1)
University Ghent Hospital
Ghent, East-Flanders, 9000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Van Langenhove, MD, PhD
University Hospital, Ghent
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2024
First Posted
May 6, 2024
Study Start
September 1, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
May 6, 2024
Record last verified: 2024-05