The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings

Not Applicable

Recruiting

• Conditions: Speech Intelligibility; Hearing Loss, Sensorineural

• 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

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2024-04-16
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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, ...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

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