Speech IntelligibilityNCT06420037
The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
A study testing Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70, Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 and Cognitive screening and vision screening in people with Speech Intelligibility and Hearing Loss, Sensorineural, run by University Ghent at 1 site in Belgium.
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 70/90 hearing aids. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Intelligibility, Hearing Loss, Sensorineural
- What is being tested?
- Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70, Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 and Cognitive screening and vision screening
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2023to 4 Oct 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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, ...)
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Being tested
- Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70, Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70, Cognitive screening and vision screening, Audiological Assessment, Questionnaires
- Medical subject headings
- Speech Intelligibility, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70Device
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 70Device
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.
Cognitive screening and vision screeningBehavioural
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 AssessmentBehavioural
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.
QuestionnairesBehavioural
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.
CognitionBehavioural
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.
Real ear measurementOther
This test will give an objective assessment of the hearing aids' configuration.
| Study group | Role | What they receive |
|---|---|---|
| Individuals between 45-80 years with bilateral hearing aids (control group) | Other | Within this control group, no changes will be made to the hearing aid settings. However, they undergo all other tests of the test protocol. Receives: Behavioral: Cognitive screening and vision screening; Behavioral: Audiological Assessment; Behavioral: Questionnaires; Behavioral: Cognition; Other: Real ear measurement |
| Individuals between 45-80 years with bilateral hearing aids (frequency compression) | Experimental | Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting. Receives: Device: Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70; Behavioral: Cognitive screening and vision screening; Behavioral: Audiological Assessment; Behavioral: Questionnaires; Behavioral: Cognition; Other: Real ear measurement |
| Individuals between 45-80 years with bilateral hearing aids (noise reduction) | Experimental | Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting. Receives: Device: Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70; Behavioral: Cognitive screening and vision screening; Behavioral: Audiological Assessment; Behavioral: Questionnaires; Behavioral: Cognition; Other: Real ear measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 10 minutes).
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.
Measured: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
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.
Measured: 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)
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.
Measured: These outcome measures will be assessed once during the first measurement (+/- 55 minutes).
Real ear measurement
Test to obtain an objective understanding of the current settings of the hearing aids.
Measured: This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes).
Screening of mild cognitive impairment (MoCA) and vision
The result (max 30) on the MoCA will be calculated.
Measured: This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Nov 2023
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech IntelligibilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah Keppler, Prof. Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420037
- Sponsor's protocol ID
- ONZ-2023-0437
- Status last verified
- Nov 2025
- First submitted
- 16 Apr 2024
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
- ClinicalTrials.gov ID
- NCT06420037
- Acronym / sponsor ID
- ONZ-2023-0437
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 17 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals between 45-80 years with bilateral hearing aids (control group) | Other | Behavioral: Cognitive screening and vision screening, Behavioral: Audiological Assessment, Behavioral: Questionnaires, Behavioral: Cognition, Other: Real ear measurementWithin 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) | Experimental | Device: Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70, Behavioral: Cognitive screening and vision screening, Behavioral: Audiological Assessment, Behavioral: Questionnaires, Behavioral: Cognition, Other: Real ear measurementWithin 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) | Experimental | Device: Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70, Behavioral: Cognitive screening and vision screening, Behavioral: Audiological Assessment, Behavioral: Questionnaires, Behavioral: Cognition, Other: Real ear measurementWithin this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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, ...)
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 |
|---|---|---|
| Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70Upon 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. | Device | Individuals between 45-80 years with bilateral hearing aids (frequency compression) |
| Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70Upon 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. | Device | Individuals between 45-80 years with bilateral hearing aids (noise reduction) |
| Cognitive screening and vision screeningThe Dutch Montreal Cognitive Assessment will be assessed. The Snellen Eye Test will be used to screen for normal or corrected-to-normal vision. | Behavioural | Individuals between 45-80 years with bilateral hearing aids (control group), Individuals between 45-80 years with bilateral hearing aids (frequency compression), Individuals between 45-80 years with bilateral hearing aids (noise reduction) |
| Audiological AssessmentThree 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. | Behavioural | Individuals between 45-80 years with bilateral hearing aids (control group), Individuals between 45-80 years with bilateral hearing aids (frequency compression), Individuals between 45-80 years with bilateral hearing aids (noise reduction) |
| QuestionnairesThree 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. | Behavioural | Individuals between 45-80 years with bilateral hearing aids (control group), Individuals between 45-80 years with bilateral hearing aids (frequency compression), Individuals between 45-80 years with bilateral hearing aids (noise reduction) |
| CognitionFour cognitive functions, important for speech understanding, will be assessed both audibly and visually: divided attention, working memory, processing speed, and cognitive flexibility and inhibition. | Behavioural | Individuals between 45-80 years with bilateral hearing aids (control group), Individuals between 45-80 years with bilateral hearing aids (frequency compression), Individuals between 45-80 years with bilateral hearing aids (noise reduction) |
| Real ear measurementThis test will give an objective assessment of the hearing aids' configuration. | Other | Individuals between 45-80 years with bilateral hearing aids (control group), Individuals between 45-80 years with bilateral hearing aids (frequency compression), Individuals between 45-80 years with bilateral hearing aids (noise reduction) |
Primary outcome
Speech reception threshold
Time frame: This outcome measure will be assessed twice during the initial measurement (both +/- 10 minutes) and once during the second measurement (+/- 10 minutes).
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.
6 secondary outcomes
Hearing related quality of life
Time frame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 10 minutes).
Fatigue assessment
Time frame: This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).
Effort assessment
Time frame: 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)
Time frame: These outcome measures will be assessed once during the first measurement (+/- 55 minutes).
Real ear measurement
Time frame: This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes).
Screening of mild cognitive impairment (MoCA) and vision
Time frame: This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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.
Hannah Keppler, Prof. Dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70, Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 and Cognitive screening and vision screening in people with Speech Intelligibility and Hearing Loss, Sensorineural, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech reception threshold (time frame: This outcome measure will be assessed twice during the initial measurement (both +/- 10 minutes) and once during the second measurement (+/- 10 minutes).). 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 18 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.