Clinical trial NCT06420037: The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
Official title: The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Speech Intelligibility
Hearing Loss, Sensorineural
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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, ...)

Primary outcomes:
measure: Speech reception threshold
timeFrame: This outcome measure will be assessed twice during the initial measurement (both +/- 10 minutes) and once during the second measurement (+/- 10 minutes).
Secondary outcomes:
measure: Hearing related quality of life
timeFrame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 10 minutes).
measure: Fatigue assessment
timeFrame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
measure: Effort assessment
timeFrame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
measure: Cognitive functioning (auditory and visual)
timeFrame: These outcome measures will be assessed once during the first measurement (+/- 55 minutes).
measure: Real ear measurement
timeFrame: This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes).
measure: Screening of mild cognitive impairment (MoCA) and vision
timeFrame: This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes).
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent
state: East-Flanders
Study officials:
affiliation: University Ghent
name: Hannah Keppler, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: