Skip to main content
Clinical Trials/NCT06420037
NCT06420037
Completed
N/A

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

University Ghent1 site in 1 country32 target enrollmentNovember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Speech Intelligibility
Sponsor
University Ghent
Enrollment
32
Locations
1
Primary Endpoint
Speech reception threshold
Status
Completed
Last Updated
5 months ago

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
October 4, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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, ...)

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).)

Study Sites (1)

Loading locations...

Similar Trials