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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannah Keppler, Prof. Dr. | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Ghent | Ghent | East-Flanders | 9000 | Belgium |
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|
| Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 | Device | 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 | Behavioral | 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 | Behavioral | 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 | Behavioral | Three questionnaires are included:
|
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| Cognition | Behavioral | 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 | Other | This test will give an objective assessment of the hearing aids' configuration. |
|
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| ID | Term |
|---|---|
| D013065 | Speech Intelligibility |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D013060 | Speech |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015351 | Vision Screening |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008403 | Mass Screening |
| D006306 | Health Surveys |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
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