Sensorineural Hearing LossNCT05568329
Appreciation for Music Processed by Hearing Aids
A study testing Hearing Aid Program in people with Sensorineural Hearing Loss, run by Purdue University at 1 site in United States.
Trial summary
Normal-hearing participants aged 18-25 with and without musical training will listen to a series of short musical samples that have been recorded through hearing aids. The music will be played at a comfortable listening level. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- Hearing Aid Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 15 May 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal hearing (audiometric thresholds <= 20 dB HL, except one that may be 25 dB HL)
- Native English speakers
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Purdue University
West Lafayette, Indiana, 47907
Joshua Alexander, Ph.D., 765-494-4091, alexan14@purdue.edu
About this study
Normal-hearing participants aged 18-25 with and without musical training will listen to a series of short musical samples that have been recorded through hearing aids. The music will be played at a comfortable listening level. Subjects will use the computer to rate the sound quality of the music on a 7-point Likert scale.
Read the detailed description
Hearing aids are designed to treat hearing loss and restore quality of life by aiding spoken communication ability. To improve a user's listening experience for speech, hearing aids process background noise, reduce amplification for loud sounds, and use adaptive directionality for different environments, along with various other features. However, while much research and attention have been placed on developing features that improve a user's listening experience for speech, research and attention are lacking on developing features that improve a user's listening experience for music.
In addition to spoken communication, music is also influential in maintaining the quality of life. Greasley et al. (2020) report that hearing aid users, especially those who play music, often experience negative emotional consequences when they disengage from music for reasons associated with how their hearing aids amplify music. They also report that two-thirds of the hearing aid users they surveyed experienced at least some problems when listening to music. This is not a trivial issue, given that music is a significant source of entertainment - Delmonte (2018) reports that Americans aged 16 to 65+ years listen to music for more than 2 hours per day.
This study will evaluate which feature or combination of features currently being used in hearing aid music programs results in the best listening experience for music. Secondary objectives of this study will be to address the lack of information in the literature about judgments of the quality music stimuli of younger listeners, to include a wider variety of culturally inclusive music samples, and to include a comparison of preferences of musician and non-musician listeners. These objectives will be pursued by comparing the efficacy of different features used in current music programs to the default speech program and if the rankings for baseline and music features are higher or lower for musicians/non-musicians.
Participants who meet the inclusion criteria (see below) will undergo an informed consent procedure, which includes a verbal and written description of the procedures to be followed, an assurance that there are no known risks to participants, an indication of the option to withdraw from the study at any time without penalty, and the name and phone numbers of the Principal Investigator. All participants will sign the IRB-approved informed-consent form. Written consent will also be obtained for participants interested in being contacted for related studies in the future.
After informed consent, participants will complete a questionnaire about their musical experience. Participants will then have their hearing screened by an undergraduate laboratory assistant (the PI is a certified and licensed audiologist). These tests involve listening to a series of short beeps at different frequencies and intensities and pressing a button when a sound is detected. Participants who do not meet the inclusion criteria will be compensated for their time completing the questionnaire and audiologic evaluation.
During the experiments, listeners will sit in a sound-treated room and listen to brief (10-15 second) music samples presented over headphones. After each presentation, listeners will indicate their response using the computer mouse by selecting one option of a 7-point rating scale on the screen. These responses will constitute the data that will be subsequently analyzed. Sessions will last about 1 to 2 hours, including breaks taken at the participants' discretion. Data for a single experiment generally can be collected in one or two sessions, therefore, participants will be under no pressure to continue their participation over an extended period.
We will use a controlled laboratory design to investigate our questions, and participants will not have access to the sound processing outside of the laboratory. Therefore, whatever experimental manipulation we introduce immediately ceases once the participant removes the headphones.
No deception ever occurs in any of these experiments.
- Conditions
- Sensorineural Hearing Loss
- Being tested
- Hearing Aid Program
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid ProgramDevice
Also called Hearing Aid Music Feature
Each subject will listen to recordings of music processed by seven different hearing aid brands set to the default "Speech in Quiet" program and the default "Music" program. Recordings (hearing aid brand x program x music sample) will be randomized from trial to trial.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid Signal Processing | Experimental | Each subject will listen to recordings of music processed by seven different hearing aid brands set to the default "Speech in Quiet" program and the default "Music" program. Recordings (hearing aid brand x program x music sample) will be randomized from trial to trial. Receives: Device: Hearing Aid Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sound Quality: Music Feature Activated vs. Deactivated
Within each hearing aid manufacturer, the mean sound quality with the music feature activated will be compared against the mean sound quality with the music feature deactivated.
Measured: 60 minutes
Secondary outcomes (2)
Sound Quality: Music Feature across Manufacturers
Across hearing aid manufacturers, the mean sound quality with the music feature activated will be compared.
Measured: 60 minutes
Effects of Music Training
Mean quality ratings for subjects with more than 5 years of formal musical training will be compared against those with less than 5 years of formal musical training.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start21 Sep 2022
- Primary completion15 May 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlexanderLab, Purdue University
- Investigators
- Joshua Alexander, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568329
- Sponsor's protocol ID
- 2022-952
- Status last verified
- Mar 2023
- First submitted
- 26 Sep 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data stored as a CSV file will be shared along with the audio recordings used to obtain the data. Individual participants' responses (sound quality rating) to each trial (audio recording) will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appreciation for Music Processed by Hearing Aids
- ClinicalTrials.gov ID
- NCT05568329
- Acronym / sponsor ID
- 2022-952
- Conditions
- Sensorineural Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 5 Oct 2022 (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.
Normal-hearing participants aged 18-25 with and without musical training will listen to a series of short musical samples that have been recorded through hearing aids. The music will be played at a comfortable listening level. Subjects will use the computer to rate the sound quality of the music on a 7-point Likert scale.
Detailed description
Hearing aids are designed to treat hearing loss and restore quality of life by aiding spoken communication ability. To improve a user's listening experience for speech, hearing aids process background noise, reduce amplification for loud sounds, and use adaptive directionality for different environments, along with various other features. However, while much research and attention have been placed on developing features that improve a user's listening experience for speech, research and attention are lacking on developing features that improve a user's listening experience for music.
In addition to spoken communication, music is also influential in maintaining the quality of life. Greasley et al. (2020) report that hearing aid users, especially those who play music, often experience negative emotional consequences when they disengage from music for reasons associated with how their hearing aids amplify music. They also report that two-thirds of the hearing aid users they surveyed experienced at least some problems when listening to music. This is not a trivial issue, given that music is a significant source of entertainment - Delmonte (2018) reports that Americans aged 16 to 65+ years listen to music for more than 2 hours per day.
This study will evaluate which feature or combination of features currently being used in hearing aid music programs results in the best listening experience for music. Secondary objectives of this study will be to address the lack of information in the literature about judgments of the quality music stimuli of younger listeners, to include a wider variety of culturally inclusive music samples, and to include a comparison of preferences of musician and non-musician listeners. These objectives will be pursued by comparing the efficacy of different features used in current music programs to the default speech program and if the rankings for baseline and music features are higher or lower for musicians/non-musicians.
Participants who meet the inclusion criteria (see below) will undergo an informed consent procedure, which includes a verbal and written description of the procedures to be followed, an assurance that there are no known risks to participants, an indication of the option to withdraw from the study at any time without penalty, and the name and phone numbers of the Principal Investigator. All participants will sign the IRB-approved informed-consent form. Written consent will also be obtained for participants interested in being contacted for related studies in the future.
After informed consent, participants will complete a questionnaire about their musical experience. Participants will then have their hearing screened by an undergraduate laboratory assistant (the PI is a certified and licensed audiologist). These tests involve listening to a series of short beeps at different frequencies and intensities and pressing a button when a sound is detected. Participants who do not meet the inclusion criteria will be compensated for their time completing the questionnaire and audiologic evaluation.
During the experiments, listeners will sit in a sound-treated room and listen to brief (10-15 second) music samples presented over headphones. After each presentation, listeners will indicate their response using the computer mouse by selecting one option of a 7-point rating scale on the screen. These responses will constitute the data that will be subsequently analyzed. Sessions will last about 1 to 2 hours, including breaks taken at the participants' discretion. Data for a single experiment generally can be collected in one or two sessions, therefore, participants will be under no pressure to continue their participation over an extended period.
We will use a controlled laboratory design to investigate our questions, and participants will not have access to the sound processing outside of the laboratory. Therefore, whatever experimental manipulation we introduce immediately ceases once the participant removes the headphones.
No deception ever occurs in any of these experiments.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid Signal Processing | Experimental | Device: Hearing Aid ProgramEach subject will listen to recordings of music processed by seven different hearing aid brands set to the default "Speech in Quiet" program and the default "Music" program. Recordings (hearing aid brand x program x music sample) will be randomized from trial to trial. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal hearing (audiometric thresholds <= 20 dB HL, except one that may be 25 dB HL)
- Native English speakers
Key exclusion criteria (1 listed)
- -
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 ProgramAlso: Hearing Aid Music FeatureEach subject will listen to recordings of music processed by seven different hearing aid brands set to the default "Speech in Quiet" program and the default "Music" program. Recordings (hearing aid brand x program x music sample) will be randomized from trial to trial. | Device | Hearing Aid Signal Processing |
Primary outcome
Sound Quality: Music Feature Activated vs. Deactivated
Time frame: 60 minutes
Within each hearing aid manufacturer, the mean sound quality with the music feature activated will be compared against the mean sound quality with the music feature deactivated.
2 secondary outcomes
Sound Quality: Music Feature across Manufacturers
Time frame: 60 minutes
Effects of Music Training
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Yes. Data stored as a CSV file will be shared along with the audio recordings used to obtain the data. Individual participants' responses (sound quality rating) to each trial (audio recording) will be provided.
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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.
Joshua Alexander principal investigator
Purdue University
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 Aid Program in people with Sensorineural Hearing Loss, run by Purdue University 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Alexander, Ph.D. (17654944091, alexan14@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sound Quality: Music Feature Activated vs. Deactivated (time frame: 60 minutes). 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 29 Mar 2023; AzTrials last refreshed its copy on 29 Oct 2026.