The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
- Conditions
- Speech IntelligibilityHearing Loss, Sensorineural
- Interventions
- Behavioral: Cognitive screening and vision screeningBehavioral: Audiological AssessmentBehavioral: QuestionnairesBehavioral: CognitionOther: Real ear measurement
- Registration Number
- NCT06420037
- Lead Sponsor
- University Ghent
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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, ...)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Individuals between 45-80 years with bilateral hearing aids (control group) Cognitive screening and vision screening 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) Real ear measurement 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) Real ear measurement 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 (control group) Real ear measurement 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 (noise reduction) Cognitive screening and vision screening 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 (control group) Audiological Assessment 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 (control group) Questionnaires 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 (control group) Cognition 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) Cognitive screening and vision screening 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 (frequency compression) Audiological Assessment 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 (frequency compression) Questionnaires 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 (frequency compression) Cognition 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) Audiological Assessment 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) Questionnaires 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) Cognition Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting.
- Primary Outcome Measures
Name Time Method Speech reception threshold 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.
- Secondary Outcome Measures
Name Time Method Effort assessment This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes). 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.
Screening of mild cognitive impairment (MoCA) and vision This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes). The result (max 30) on the MoCA will be calculated.
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). 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.
Fatigue assessment This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes). 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.
Real ear measurement This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes). Test to obtain an objective understanding of the current settings of the hearing aids.
Cognitive functioning (auditory and visual) These outcome measures will be assessed once during the first measurement (+/- 55 minutes). 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.
Trial Locations
- Locations (1)
University Ghent
🇧🇪Ghent, East-Flanders, Belgium