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

May 1, 2024 updated by: University Ghent
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Individuals with cognitive impairment and/or hearing loss

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals (>45 years) with mild cognitive impairment and hearing loss
All tests will be administered.
Behavioral: 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.
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
Individuals (>45 years) with dementia (Alzheimer, vascular or mixed) and hearing loss
All tests will be administered.
Behavioral: 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.
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
Individuals (>45 years) with age-normal cognition and hearing loss
All tests will be administered.
Behavioral: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing status
Time Frame: This 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.
This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 20 minutes.
MoCA-HI
Time Frame: 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.
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
Time Frame: This 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.
This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 15 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

University Hospital, Ghent

Investigators

  • Principal Investigator: Tim Van Langenhove, MD, PhD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2023-0147

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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