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Clinical Trials/NCT03279510
NCT03279510
Completed
N/A

Hearing Aids and the Brain

VA Office of Research and Development1 site in 1 country20 target enrollmentMarch 22, 2018
ConditionsHearing Loss

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
VA Office of Research and Development
Enrollment
20
Locations
1
Primary Endpoint
Frequency following response timing
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Hearing aids are being fit on inexperienced hearing aid users and the short-term and long-term effects are measured. This research aims to improve understanding of the individual factors that contribute to receiving benefit from hearing aids and lead to more individualized treatment of hearing loss.

Detailed Description

Hearing aids are used to improve audibility for patients with hearing loss and improve speech perception. In addition to these immediate benefits, amplification has the potential to have long-term effects on higher level auditory processing abilities, such as cognition or other abilities required for complex listening tasks. These long-term acclimatization effects are not well understood and merit further behavioral and physiological examination. Hearing aids will be fit on inexperienced hearing aid users and outcome measures will be used to determine immediate and long-term effects of hearing aids. This research may provide a more detailed view of individual differences that contribute to receiving benefit from a hearing aid and may lead to more individualized treatment of hearing loss.

Registry
clinicaltrials.gov
Start Date
March 22, 2018
End Date
January 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 50 years of age or older
  • Bilateral, mild to moderately severe hearing loss
  • Inexperienced hearing aid users

Exclusion Criteria

  • Subject deciding that they do not wish to wear hearing aids as necessitated per study protocol
  • Audiometric thresholds that suggest research stimuli would not be audible
  • Conductive hearing loss and/or other significant ear or hearing problems
  • Non-native English speakers
  • Conditions or circumstances that would preclude a participant from wearing hearing aids consistently or finishing the study
  • An inability to perform or complete the experimental tasks

Outcomes

Primary Outcomes

Frequency following response timing

Time Frame: Approximately 1 year

Timing measured by cross-correlation between stimulus and response

Evoked potential amplitude

Time Frame: Approximately 1 year

Amplitude will be measured in microvolts

Ongoing electroencephalography power

Time Frame: Approximately 1 year

EEG power as a function of frequency recorded during words-in-noise measure

Listening invested/required effort

Time Frame: Approximately 1 year

Participants' rating of the effort required (0-9) and invested (0-9) for listening task

Word-in-noise perception testing

Time Frame: Approximately 1 year

Signal-to-noise ratio at which participant correctly understands 50% of speech in noise using WIN test

Working memory testing

Time Frame: Approximately 1 year

Performance on auditory working memory task

Evoked potential latency

Time Frame: Approximately 1 year

Latency will be measured in milliseconds

Frequency following response magnitude

Time Frame: Approximately 1 year

Magnitude of response measured in nanovolts

Reading Span

Time Frame: Approximately 1 year

Percent correct recall on working memory task

Hearing aid usage

Time Frame: Approximately 1 year

Data logging from the hearing aid will provide usage in hours per day

Glasgow Hearing Aid Benefit Profile (GHABP)

Time Frame: Approximately 1 year

Participants rating on five-point scale their perceived initial (i.e., unaided) hearing disability, initial handicap, aided benefit, aided handicap, HA use and HA satisfaction in four listening situations

Montreal Cognitive Assessment score

Time Frame: Approximately 1 year

Assessment score from 1 to 30

Study Sites (1)

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