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OpenTrials
Completed

NCT Number: NCT03279510

Hearing Aids and the Brain

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hearing aids

Device

Subjects are fit with hearing aids.

Primary outcomes

  1. Evoked potential latency

    Time frame: Approximately 1 year

    Latency will be measured in milliseconds

  2. Evoked potential amplitude

    Time frame: Approximately 1 year

    Amplitude will be measured in microvolts

  3. Frequency following response magnitude

    Time frame: Approximately 1 year

    Magnitude of response measured in nanovolts

  4. Frequency following response timing

    Time frame: Approximately 1 year

    Timing measured by cross-correlation between stimulus and response

  5. Ongoing electroencephalography power

    Time frame: Approximately 1 year

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

  6. Montreal Cognitive Assessment score

    Time frame: Approximately 1 year

    Assessment score from 1 to 30

  7. Reading Span

    Time frame: Approximately 1 year

    Percent correct recall on working memory task

  8. Hearing aid usage

    Time frame: Approximately 1 year

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

  9. 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

  10. Listening invested/required effort

    Time frame: Approximately 1 year

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

  11. Working memory testing

    Time frame: Approximately 1 year

    Performance on auditory working memory task

  12. 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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 12, 2017
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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