DementiaMoCA-HINCT06400173
Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment
An observational study of Dementia and Hearing Loss, run by University Ghent at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Dementia, Hearing Loss
- What is being tested?
- Cognitive screening and Audiological Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Adult, Older adult
Study population: Individuals with cognitive impairment and/or hearing loss
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Tim Van Langenhove, MD, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
University Ghent Hospital
Ghent, East-Flanders, 9000
Tim Van Langenhove, MD, PhD, tim.vanlangenhove@uzgent.be
About this study
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.
- Conditions
- Dementia, Hearing Loss
- Being tested
- Cognitive screening, Audiological Assessment
- Keywords
- Cognitive screening, Montreal Cognitive Assessment
- Medical subject headings
- Dementia, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive screeningBehavioural
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 AssessmentBehavioural
Four audiological tests are included in the audiological assessment
- Tympanometry to assss the middle ear status
- Pure-tone audiometry with headphone to evaluate the hearing thresholds
- Speech audiometry in free field to assess the ability to understand spoken words in the presence of background noise
- The hAVICOP questionnaire to assess the hearing-related quality of life
| Study group | Role | What they receive |
|---|---|---|
| Individuals (>45 years) with mild cognitive impairment and hearing loss | All tests will be administered. Receives: Behavioral: Cognitive screening; Behavioral: Audiological Assessment | |
| Individuals (>45 years) with dementia (Alzheimer, vascular or mixed) and hearing loss | All tests will be administered. Receives: Behavioral: Cognitive screening; Behavioral: Audiological Assessment | |
| Individuals (>45 years) with age-normal cognition and hearing loss | All tests will be administered. Receives: Behavioral: Cognitive screening; Behavioral: Audiological Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Tim Van Langenhove, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400173
- Sponsor's protocol ID
- ONZ-2023-0147
- Acronym
- MoCA-HI
- Status last verified
- May 2024
- First submitted
- 12 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Of The Flemish Montreal Cognitive Assessment (MoCA) For Persons With Hearing Impairment
- ClinicalTrials.gov ID
- NCT06400173
- Acronym / sponsor ID
- MoCA-HI / ONZ-2023-0147
- Conditions
- Dementia, Hearing Loss
- Keywords
- Cognitive screening, Montreal Cognitive Assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals (>45 years) with mild cognitive impairment and hearing loss | – | Behavioral: Cognitive screening, Behavioral: Audiological AssessmentAll tests will be administered. |
| Individuals (>45 years) with dementia (Alzheimer, vascular or mixed) and hearing loss | – | Behavioral: Cognitive screening, Behavioral: Audiological AssessmentAll tests will be administered. |
| Individuals (>45 years) with age-normal cognition and hearing loss | – | Behavioral: Cognitive screening, Behavioral: Audiological AssessmentAll tests will be administered. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals with cognitive impairment and/or hearing loss
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- (History of) neurological problems (brain tumor, epilepsy, history of stroke, etc.)
- Use of influencing medication (e.g., Ritalin and antidepressants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive screeningThe 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. | Behavioural | Individuals (>45 years) with age-normal cognition and hearing loss, Individuals (>45 years) with dementia (Alzheimer, vascular or mixed) and hearing loss, Individuals (>45 years) with mild cognitive impairment and hearing loss |
| Audiological AssessmentFour 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 | Behavioural | Individuals (>45 years) with age-normal cognition and hearing loss, Individuals (>45 years) with dementia (Alzheimer, vascular or mixed) and hearing loss, Individuals (>45 years) with mild cognitive impairment and hearing loss |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Van Langenhove, MD, PhD contact
Tim Van Langenhove, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Hearing Loss, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrien Kestens, PhD (003293320865, katrien.kestens@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing status (time frame: This parameter will be assessed once during the first study visit of the patient. Test duration is approximately 20 minutes.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.