The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
NCT ID: NCT06420037
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2023-11-01
2024-10-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
SINGLE
Study Groups
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Individuals between 45-80 years with bilateral hearing aids (control group)
Within this control group, no changes will be made to the hearing aid settings. However, they undergo all other tests of the test protocol.
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:
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.
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.
Real ear measurement
This test will give an objective assessment of the hearing aids' configuration.
Individuals between 45-80 years with bilateral hearing aids (frequency compression)
Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.
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.
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:
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.
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.
Real ear measurement
This test will give an objective assessment of the hearing aids' configuration.
Individuals between 45-80 years with bilateral hearing aids (noise reduction)
Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid 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.
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:
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.
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.
Real ear measurement
This test will give an objective assessment of the hearing aids' configuration.
Interventions
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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.
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:
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.
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.
Real ear measurement
This test will give an objective assessment of the hearing aids' configuration.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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, ...)
45 Years
80 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
Responsible Party
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Principal Investigators
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Hannah Keppler, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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University Ghent
Ghent, East-Flanders, Belgium
Countries
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Other Identifiers
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ONZ-2023-0437
Identifier Type: -
Identifier Source: org_study_id
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