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Hearing Aids and the Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279510
Recruitment Status : Active, not recruiting
First Posted : September 12, 2017
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: hearing aids Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hearing Aids and the Brain
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
Experimental: Hearing aids
All study participants will be fit with hearing aids.
Device: hearing aids
Subjects are fit with hearing aids.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279510


Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Curtis J. Billings, PhD VA Portland Health Care System, Portland, OR
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03279510    
Other Study ID Numbers: C2396-P
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
auditory perception
hearing
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms