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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

Tracking Information
First Submitted Date  ICMJE August 23, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE March 22, 2018
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Evoked potential latency [ Time Frame: Approximately 1 year ]
    Latency will be measured in milliseconds
  • Evoked potential amplitude [ Time Frame: Approximately 1 year ]
    Amplitude will be measured in microvolts
  • Frequency following response magnitude [ Time Frame: Approximately 1 year ]
    Magnitude of response measured in nanovolts
  • Frequency following response timing [ Time Frame: Approximately 1 year ]
    Timing measured by cross-correlation between stimulus and response
  • Ongoing electroencephalography power [ Time Frame: Approximately 1 year ]
    EEG power as a function of frequency recorded during words-in-noise measure
  • Montreal Cognitive Assessment score [ Time Frame: Approximately 1 year ]
    Assessment score from 1 to 30
  • 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
  • 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
  • Listening invested/required effort [ Time Frame: Approximately 1 year ]
    Participants' rating of the effort required (0-9) and invested (0-9) for listening task
  • Working memory testing [ Time Frame: Approximately 1 year ]
    Performance on auditory working memory task
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • Evoked potential latency [ Time Frame: Approximately 1 year ]
    Latency will be measured in milliseconds
  • Evoked potential amplitude [ Time Frame: Approximately 1 year ]
    Amplitude will be measured in microvolts
  • Evoked potential reaction time [ Time Frame: Approximately 1 year ]
    Behavioral reaction time resulting from target identification (measured in milliseconds)
  • Evoked potential accuracy [ Time Frame: Approximately 1 year ]
    Behavioral percent correct resulting from target identification
  • Frequency following response magnitude [ Time Frame: Approximately 1 year ]
    Magnitude of response measured in nanovolts
  • Frequency following response timing [ Time Frame: Approximately 1 year ]
    Timing measured by cross-correlation between stimulus and response
  • Ongoing electroencephalography power [ Time Frame: Approximately 1 year ]
    EEG power as a function of frequency recorded during words-in-noise measure
  • Montreal Cognitive Assessment score [ Time Frame: Approximately 1 year ]
    Assessment score from 1 to 30
  • 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
  • Sentence-in-noise perception testing [ Time Frame: Approximately 1 year ]
    Percent of target words correctly identified
  • 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
  • Listening invested/required effort [ Time Frame: Approximately 1 year ]
    Participants' rating of the effort required (0-9) for listening task
  • Listening Effort Dual Task Test [ Time Frame: Approximately 1 year ]
    Performance on the primary and secondary tasks will be measured
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hearing Aids and the Brain
Official Title  ICMJE Hearing Aids and the Brain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss
Intervention  ICMJE Device: hearing aids
Subjects are fit with hearing aids.
Study Arms  ICMJE Experimental: Hearing aids
All study participants will be fit with hearing aids.
Intervention: Device: hearing aids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2024
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03279510
Other Study ID Numbers  ICMJE C2396-P
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Curtis J. Billings, PhD VA Portland Health Care System, Portland, OR
PRS Account VA Office of Research and Development
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP