The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Ghent
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Speech reception threshold
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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, ...)
Arms & Interventions
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.
Intervention: Cognitive screening and vision screening (Behavioral)
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.
Intervention: Audiological Assessment (Behavioral)
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.
Intervention: Questionnaires (Behavioral)
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.
Intervention: Cognition (Behavioral)
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.
Intervention: Real ear measurement (Other)
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.
Intervention: Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 (Device)
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.
Intervention: Cognitive screening and vision screening (Behavioral)
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.
Intervention: Audiological Assessment (Behavioral)
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.
Intervention: Questionnaires (Behavioral)
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.
Intervention: Cognition (Behavioral)
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.
Intervention: Real ear measurement (Other)
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.
Intervention: Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 (Device)
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.
Intervention: Cognitive screening and vision screening (Behavioral)
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.
Intervention: Audiological Assessment (Behavioral)
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.
Intervention: Questionnaires (Behavioral)
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.
Intervention: Cognition (Behavioral)
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.
Intervention: Real ear measurement (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Effort assessment(This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes).)
- Screening of mild cognitive impairment (MoCA) and vision(This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes).)
- 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).)
- Real ear measurement(This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes).)
- Cognitive functioning (auditory and visual)(These outcome measures will be assessed once during the first measurement (+/- 55 minutes).)