Hearing LossNCT03279510
Hearing Aids and the Brain
A study testing hearing aids in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- hearing aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- Bilateral, mild to moderately severe hearing loss
- Inexperienced hearing aid users
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- hearing aids
- Keywords
- auditory perception, hearing
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing aidsDevice
Subjects are fit with hearing aids.
| Study group | Role | What they receive |
|---|---|---|
| Hearing aids | Experimental | All study participants will be fit with hearing aids. Receives: Device: hearing aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evoked potential latency
Latency will be measured in milliseconds
Measured: Approximately 1 year
Evoked potential amplitude
Amplitude will be measured in microvolts
Measured: Approximately 1 year
Frequency following response magnitude
Magnitude of response measured in nanovolts
Measured: Approximately 1 year
Frequency following response timing
Timing measured by cross-correlation between stimulus and response
Measured: Approximately 1 year
Ongoing electroencephalography power
EEG power as a function of frequency recorded during words-in-noise measure
Measured: Approximately 1 year
Montreal Cognitive Assessment score
Assessment score from 1 to 30
Measured: Approximately 1 year
Reading Span
Percent correct recall on working memory task
Measured: Approximately 1 year
Hearing aid usage
Data logging from the hearing aid will provide usage in hours per day
Measured: Approximately 1 year
Word-in-noise perception testing
Signal-to-noise ratio at which participant correctly understands 50% of speech in noise using WIN test
Measured: Approximately 1 year
Listening invested/required effort
Participants' rating of the effort required (0-9) and invested (0-9) for listening task
Measured: Approximately 1 year
Working memory testing
Performance on auditory working memory task
Measured: Approximately 1 year
Glasgow Hearing Aid Benefit Profile (GHABP)
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
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start22 Mar 2018
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Curtis J. Billings, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279510
- Sponsor's protocol ID
- C2396-P
- Status last verified
- Mar 2023
- First submitted
- 23 Aug 2017
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Aids and the Brain
- ClinicalTrials.gov ID
- NCT03279510
- Acronym / sponsor ID
- C2396-P
- Conditions
- Hearing Loss
- Keywords
- auditory perception, hearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing aids | Experimental | Device: hearing aidsAll study participants will be fit with hearing aids. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 years of age or older
- Bilateral, mild to moderately severe hearing loss
- Inexperienced hearing aid users
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hearing aidsSubjects are fit with hearing aids. | Device | Hearing aids |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis J. Billings, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hearing aids in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evoked potential latency (time frame: Approximately 1 year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023; AzTrials last refreshed its copy on 28 Oct 2026.