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

Dementia Clinical Trial

— MoCA-HI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400173
• Other study ID #: ONZ-2023-0147
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University Ghent
• Contact: Katrien Kestens, PhD
• Phone: 003293320865
• Email: katrien.kestens[@]ugent.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Deafness
• Dementia
• Hearing Loss

Intervention

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.
• Audiological Assessment
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

Locations

Country	Name	City	State
Belgium	University Ghent Hospital	Ghent	East-Flanders

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.