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

NCT ID: NCT06400173

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia Hearing Loss

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Individuals (>45 years) with mild cognitive impairment and hearing loss

All tests will be administered.

Cognitive screening

Intervention Type BEHAVIORAL

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.

Audiological Assessment

Intervention Type BEHAVIORAL

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

Individuals (>45 years) with dementia (Alzheimer, vascular or mixed) and hearing loss

All tests will be administered.

Cognitive screening

Intervention Type BEHAVIORAL

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.

Audiological Assessment

Intervention Type BEHAVIORAL

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

Individuals (>45 years) with age-normal cognition and hearing loss

All tests will be administered.

Cognitive screening

Intervention Type BEHAVIORAL

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.

Audiological Assessment

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive screening

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.

Intervention Type BEHAVIORAL

Audiological Assessment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Van Langenhove, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Ghent Hospital

Ghent, East-Flanders, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Katrien Kestens, PhD

Role: CONTACT

003293320865

Tim Van Langenhove, MD, PhD

Role: CONTACT

Facility Contacts

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Tim Van Langenhove, MD, PhD

Role: primary

Other Identifiers

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ONZ-2023-0147

Identifier Type: -

Identifier Source: org_study_id

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