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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Joshua Alexander, Ph.D. contact

17654944091

alexan14@purdue.edu

United States1 site, 1 recruiting
  • Purdue University

    West Lafayette, Indiana, 47907

    Joshua Alexander, Ph.D., 765-494-4091, alexan14@purdue.edu

    Recruiting

Other trials in United States

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.

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 groups in NCT05568329
Study groupRoleWhat they receive
Hearing Aid Signal ProcessingExperimentalEach 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted5 Oct 2022
  2. Study start21 Sep 2022
  3. Primary completion15 May 2023 (estimated)
  4. Study completion15 May 2023 (estimated)

Resources

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)
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.

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.

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