The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
1 other identifier
interventional
32
1 country
1
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 70/90 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2024
CompletedNovember 18, 2025
November 1, 2025
11 months
April 16, 2024
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Hearing related quality of life
This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 10 minutes).
Fatigue assessment
This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
Effort assessment
This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
Cognitive functioning (auditory and visual)
These outcome measures will be assessed once during the first measurement (+/- 55 minutes).
Real ear measurement
This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes).
- +1 more secondary outcomes
Study Arms (3)
Individuals between 45-80 years with bilateral hearing aids (control group)
OTHERWithin this control group, no changes will be made to the hearing aid settings. However, they undergo all other tests of the test protocol.
Individuals between 45-80 years with bilateral hearing aids (frequency compression)
EXPERIMENTALWithin this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.
Individuals between 45-80 years with bilateral hearing aids (noise reduction)
EXPERIMENTALWithin this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.
Interventions
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.
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.
The Dutch Montreal Cognitive Assessment will be assessed. The Snellen Eye Test will be used to screen for normal or corrected-to-normal vision.
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.
Three questionnaires are included: 1. 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.) 2. the FAS (fatigue assessment scale) to assess how you usually feel 3. the EEAS (extended effort assessment scale) to assess how you experience listening in everyday life.
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.
This test will give an objective assessment of the hearing aids' configuration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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, ...)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
Study Sites (1)
University Ghent
Ghent, East-Flanders, 9000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hannah Keppler, Prof. Dr.
University Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2024
First Posted
May 17, 2024
Study Start
November 1, 2023
Primary Completion
October 4, 2024
Study Completion
October 4, 2024
Last Updated
November 18, 2025
Record last verified: 2025-11