The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings

Hearing Loss, Sensorineural Clinical Trial

Official title:

The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420037
• Other study ID #: ONZ-2023-0437
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University Ghent
• Contact: Louise Van Goylen, PhD
• Phone: +32484927235
• Email: louise.vangoylen[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to optimize hearing aid benefit based on the individual auditory-cognitive need using different hearing aid features in first-time hearing aid users between 45-80 years old with bilateral Phonak Audéo Paradise/Lumity 70 hearing aids. The main questions it aims to answer are:

Does cognitive functioning affect hearing aid benefit? How can hearing aid fitting be optimized based on the individual auditory-cognitive profile?

The hypothesis posits that cognitive abilities influence the effectiveness of hearing aids, alongside hearing status. Furthermore, if features of hearing aids improve speech understanding and listening effort, it is proposed that individuals with lower cognitive functioning will experience heightened benefits from hearing aids.

The study will consist of three groups: one control group and two groups where one different feature will be modified.

Participants will be tested at baseline measurement, including:

• screening tests

• audiological tests

• questionnaires

• cognitive tests

• real-ear-measurement

Following this, participants will be divided in one of the three groups, after which speech audiometry will be repeated. After a 4-week acclimatization period, the second measurement will take place, repeating speech audiometry and questionnaires. Subsequently, the hearing aid settings will be restored to their initial configuration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Dutch-speaking individuals aged between 45-80 years old

• individuals with normal vision (with glasses or lenses if needed)

• individuals with age-related hearing loss

• individuals with bilateral hearing aids (Phonak Audéo Paradise/Lumity 70)

• individuals who are capable to give consent to participate in the study themselves

Exclusion Criteria:

• user of cochlear implants

• use of influencing medication (for example: Rilatin and antidepressants)

• learning disabilities (for example: dyslexia and dyscalculia)

• (history of) neurological problems (brain tumor, epilepsy, history of stroke, ...)

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Speech Intelligibility

Intervention

Device:
• Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70
Upon enrollment, each participant will be allocated to one of three research groups and participants will remain unaware of their group assignment. This groups will undergo a slight modification, namely frequency compression turned off, to the basic setting.
• Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70
Upon enrollment, each participant will be allocated to one of three research groups and participants will remain unaware of their group assignment. This groups will undergo a slight modification, namely noise reduction turned off, to the basic setting.

Behavioral:
• Cognitive screening and vision screening
The Dutch Montreal Cognitive Assessment will be assessed. The Snellen Eye Test will be used to screen for normal or corrected-to-normal vision.
• Audiological Assessment
Three audiological tests are included: 1) Tympanometry to assess 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 sentences in quiet and in the presence of background noise.
• Questionnaires
Three questionnaires are included: The HAVICOP questionnaire to assess the hearing-related quality of life (Ceuleers, D., Baudonck, N., Keppler, H., Kestens, K., Dhooge, I., & Degeest, S. (2023). Development of the hearing-related quality of life questionnaire for auditory-visual, cognitive and psychosocial functioning (hAVICOP). Journal of communication disorders, 101, 106291.) the FAS (fatigue assessment scale) to assess how you usually feel the EEAS (extended effort assessment scale) to assess how you experience listening in everyday life.
• Cognition
Four cognitive functions, important for speech understanding, will be assessed both audibly and visually: divided attention, working memory, processing speed, and cognitive flexibility and inhibition.

Other:
• Real ear measurement
This test will give an objective assessment of the hearing aids' configuration.

Locations

Country	Name	City	State
Belgium	University Ghent	Ghent	East-Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech reception threshold	Based on the results of the speech understanding task, the speech reception threshold will give an indication of the ability to understand spoken sentences in quiet and noise.	This outcome measure will be assessed twice during the initial measurement (both +/- 10 minutes) and once during the second measurement (+/- 10 minutes).
Secondary	Hearing related quality of life	Thirty-five sentences should be responded using a VAS (0-100). Mean scores will be calculated for each subdomain separately (auditory-visual, cognitive, and psychosocial functioning) as well as combined within a total score; the worse one's hearing-related quality of life, the lower the score.	This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 10 minutes).
Secondary	Fatigue assessment	Ten sentences should be responded based on five categories, ranging from Never to Always: 1 = Never; 2 = Sometimes; 3 = Frequently; 4 = Often; and 5 = Always.	This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
Secondary	Effort assessment	Ten sentences should be responded using a VAS (0-100). Mean scores will be calculated for each sentence. The lower the score, the lower the effort.	This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
Secondary	Cognitive functioning (auditory and visual)	Cognitive functions such as 'divided attention', 'working memory', 'processing speed', and 'flexibility and inhibition' will be assessed both audibly and visually. Mean scores and average reaction times will be computed.	These outcome measures will be assessed once during the first measurement (+/- 55 minutes).
Secondary	Real ear measurement	Test to obtain an objective understanding of the current settings of the hearing aids.	This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes).
Secondary	Screening of mild cognitive impairment (MoCA) and vision	The result (max 30) on the MoCA will be calculated.	This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes).