Auditory Perceptual DisordersNCT04431622
Objective Measurement of Hearing Aid Benefit
A study testing Hearing aid amplification algorithms in people with Auditory Perceptual Disorders and Age-related Hearing Loss, run by University of Maryland, College Park.
Trial summary
Hearing loss is a critical health concern in the rapidly aging population, affecting approximately 22 million older individuals in the United States. Yet, only 30% of individuals who would benefit from the use of hearing aids regularly use them. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Auditory Perceptual Disorders, Age-related Hearing Loss
- What is being tested?
- Hearing aid amplification algorithms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Aug 2027
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aims 1 and 2 age ranges: 18-35 and 60-75
- Aim 3 age range: 50 to 85
- Aims 1 and 2 hearing levels: 1) Normal hearing thresholds defined as pure-tone thresholds ≤ 20 decibel (dB) hearing level (HL) from 125 to 4000 Hz and ≤ 30 dB HL at 6000 and 8000 Hz bilaterally, or 2) Mild to moderate sensorineural hearing loss defined as thresholds within 5 dB of 30 dB HL at 500 Hz, 50 dB HL at 1000 and 2000 Hz, and 60 dB HL at 4000 Hz.
- Aim 3 hearing level: Symmetric hearing thresholds with no interaural difference ≥ 15 dB HL at ≥ 2 frequencies.
- Intelligent Quotients ≥ 85 based on the Wechsler Abbreviated Scale of Intelligence (Psychological Corp., New York)
- Scores ≥ 24 on the Montreal Cognitive Assessment
Who cannot join
- Neurological disorders
- Middle ear pathology
- Nonnative English speakers
About this study
Hearing loss is a critical health concern in the rapidly aging population, affecting approximately 22 million older individuals in the United States. Yet, only 30% of individuals who would benefit from the use of hearing aids regularly use them. This project aims to improve the benefit of hearing aids for older adults through incorporation of objective neural measures to assess effects of hearing aid algorithms.
Read the detailed description
Hearing loss is among the top three major health conditions in older adults and has been identified as a major modifiable risk factor for dementia. It is therefore imperative that older adults receive effective treatment for hearing loss in a timely manner to prevent losses in social, emotional, and cognitive function. The current hearing aid fitting is based on audiometric thresholds, but this approach does not account for large individual differences in auditory temporal perception and cognitive ability that may affect speech understanding in challenging listening environments. At present, there is a gap in knowledge of how best to fit hearing aids for individual listeners. The long-term goal is to improve the benefit of hearing aids for older adults so that they can maintain independence and quality of life. The overall objective of this proposal is to identify the neural temporal processing mechanisms associated with individual differences in hearing aid benefit in older adults with similar audiograms. The investigators will use the innovative approach of combining complementary neural and behavioral measures to assess the effects of hearing aid amplification on speech perception and effortful listening. The central hypothesis is that the neural representation of the temporal envelope of speech can be used to predict hearing aid benefit in older adults with hearing loss. The central hypothesis will be tested through the pursuit of three aims: (1) Measure the extent to which amplification distorts the neural and perceptual processing of temporal cues; (2) Quantify reductions in temporal envelope tracking and increases in cognitive effort associated with amplification algorithms that distort the temporal envelope of the speech signal; and (3) Investigate the use of objective physiological measures of temporal processing to predict hearing aid benefit. The expected outcome is the development of an objective, neurophysiological tool for use in the design and fitting of advanced algorithms to maximize speech perception in a variety of listening environments. This outcome is expected to have a positive impact on the treatment of hearing loss and its sequelae in older adults, because it will lead to a better understanding of the neural mechanisms contributing to successful use of hearing aids.
- Being tested
- Hearing aid amplification algorithms
- Medical subject headings
- Auditory Perceptual Disorders, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aid amplification algorithmsDevice
The investigators will use stimulus waveforms that have been amplified and recorded for each individual's hearing loss. These waveforms will be created using Desired Sensation Level, Version 5-C hearing aid targets on a continuum of increased signal manipulation. The NIH-funded open hearing aid platform will be used to provide precise control over hearing aid parameters to create waveforms with linear and fast-acting compression amplification. A third set of waveforms will be created using a current clinical hearing aid that uses typical noise reduction and compression parameters. Investigating the effects of hearing aid algorithms in young normal-hearing and older normal-hearing listeners will aid in interpretation of these effects in the older hearing-impaired listeners.
| Study group | Role | What they receive |
|---|---|---|
| Effects of hearing aid algorithms | Experimental | Neural processing and cognitive effort will be assessed in individuals who listen to stimuli generated with linear and fast-acting compression hearing aid algorithms and with actual hearing aids. Receives: Device: Hearing aid amplification algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural response fidelity
Neuroelectric and neuromagnetic responses are recorded to amplified one-minute speech samples. Reconstruction of the speech envelope will be performed using a linear reconstruction matrix estimated via boosting. Reconstruction success is measured by the linear correlation between the reconstructed and the acoustic speech envelope.
Measured: Immediately post-treatment
Secondary outcomes (1)
Cognitive effort
Cognitive effort is inferred from pupillometry data Growth-curve analysis will be used to determine pupil response amplitude.
Measured: Immediately post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study startJun 2022 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Why it stopped: This study did not receive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory Perceptual DisordersStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Anderson, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431622
- Sponsor's protocol ID
- 415685-15
- Status last verified
- May 2022
- First submitted
- 17 Mar 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of data and other research products shall occur during the project, if appropriate, or at the end of the project, consistent with practices in our field. De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. Research products from this project will be archived at the Digital Repository at the University of Maryland (DRUM) unless a more appropriate facility can be identified. DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse. All records in DRUM are assigned a persistent Digital Object Identifier (DOI) to support consistent discovery and citation. The project description will be automatically indexed in Google Scholar to support global discovery.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Measurement of Hearing Aid Benefit
- ClinicalTrials.gov ID
- NCT04431622
- Acronym / sponsor ID
- 415685-15
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 16 Jun 2020 (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 loss is a critical health concern in the rapidly aging population, affecting approximately 22 million older individuals in the United States. Yet, only 30% of individuals who would benefit from the use of hearing aids regularly use them. This project aims to improve the benefit of hearing aids for older adults through incorporation of objective neural measures to assess effects of hearing aid algorithms.
Detailed description
Hearing loss is among the top three major health conditions in older adults and has been identified as a major modifiable risk factor for dementia. It is therefore imperative that older adults receive effective treatment for hearing loss in a timely manner to prevent losses in social, emotional, and cognitive function. The current hearing aid fitting is based on audiometric thresholds, but this approach does not account for large individual differences in auditory temporal perception and cognitive ability that may affect speech understanding in challenging listening environments. At present, there is a gap in knowledge of how best to fit hearing aids for individual listeners. The long-term goal is to improve the benefit of hearing aids for older adults so that they can maintain independence and quality of life. The overall objective of this proposal is to identify the neural temporal processing mechanisms associated with individual differences in hearing aid benefit in older adults with similar audiograms. The investigators will use the innovative approach of combining complementary neural and behavioral measures to assess the effects of hearing aid amplification on speech perception and effortful listening. The central hypothesis is that the neural representation of the temporal envelope of speech can be used to predict hearing aid benefit in older adults with hearing loss. The central hypothesis will be tested through the pursuit of three aims: (1) Measure the extent to which amplification distorts the neural and perceptual processing of temporal cues; (2) Quantify reductions in temporal envelope tracking and increases in cognitive effort associated with amplification algorithms that distort the temporal envelope of the speech signal; and (3) Investigate the use of objective physiological measures of temporal processing to predict hearing aid benefit. The expected outcome is the development of an objective, neurophysiological tool for use in the design and fitting of advanced algorithms to maximize speech perception in a variety of listening environments. This outcome is expected to have a positive impact on the treatment of hearing loss and its sequelae in older adults, because it will lead to a better understanding of the neural mechanisms contributing to successful use of hearing aids.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effects of hearing aid algorithms | Experimental | Device: Hearing aid amplification algorithmsNeural processing and cognitive effort will be assessed in individuals who listen to stimuli generated with linear and fast-acting compression hearing aid algorithms and with actual hearing aids. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aims 1 and 2 age ranges: 18-35 and 60-75
- Aim 3 age range: 50 to 85
- Aims 1 and 2 hearing levels: 1) Normal hearing thresholds defined as pure-tone thresholds ≤ 20 decibel (dB) hearing level (HL) from 125 to 4000 Hz and ≤ 30 dB HL at 6000 and 8000 Hz bilaterally, or 2) Mild to moderate sensorineural hearing loss defined as thresholds within 5 dB of 30 dB HL at 500 Hz, 50 dB HL at 1000 and 2000 Hz, and 60 dB HL at 4000 Hz.
- Aim 3 hearing level: Symmetric hearing thresholds with no interaural difference ≥ 15 dB HL at ≥ 2 frequencies.
- Intelligent Quotients ≥ 85 based on the Wechsler Abbreviated Scale of Intelligence (Psychological Corp., New York)
Key exclusion criteria (3 listed)
- Neurological disorders
- Middle ear pathology
- Nonnative English speakers
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 aid amplification algorithmsThe investigators will use stimulus waveforms that have been amplified and recorded for each individual's hearing loss. These waveforms will be created using Desired Sensation Level, Version 5-C hearing aid targets on a continuum of increased signal manipulation. The NIH-funded open hearing aid platform will be used to provide precise control over hearing aid parameters to create waveforms with linear and fast-acting compression amplification. A third set of waveforms will be created using a current clinical hearing aid that uses typical noise reduction and compression parameters. Investigating the effects of hearing aid algorithms in young normal-hearing and older normal-hearing listeners will aid in interpretation of these effects in the older hearing-impaired listeners. | Device | Effects of hearing aid algorithms |
Primary outcome
Neural response fidelity
Time frame: Immediately post-treatment
Neuroelectric and neuromagnetic responses are recorded to amplified one-minute speech samples. Reconstruction of the speech envelope will be performed using a linear reconstruction matrix estimated via boosting. Reconstruction success is measured by the linear correlation between the reconstructed and the acoustic speech envelope.
1 secondary outcome
Cognitive effort
Time frame: Immediately post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: Yes. Publication of data and other research products shall occur during the project, if appropriate, or at the end of the project, consistent with practices in our field. De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. Research products from this project will be archived at the Digital Repository at the University of Maryland (DRUM) unless a more appropriate facility can be identified. DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse. All records in DRUM are assigned a persistent Digital Object Identifier (DOI) to support consistent discovery and citation. The project description will be automatically indexed in Google Scholar to support global discovery.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aid amplification algorithms in people with Auditory Perceptual Disorders and Age-related Hearing Loss, run by University of Maryland, College Park.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Neural response fidelity (time frame: Immediately post-treatment). 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 23 May 2022.