Appreciation for Music Processed by Hearing Aids

Sensorineural Hearing Loss Clinical Trial

Official title:

Appreciation for Music Processed by Hearing Aids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05568329
• Other study ID #: 2022-952
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: March 2023
• Source: Purdue University
• Contact: Joshua Alexander, Ph.D.
• Phone: 17654944091
• Email: alexan14[@]purdue.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Subjects will use the computer to rate the sound quality of the music on a 7-point Likert scale.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Normal hearing (audiometric thresholds <= 20 dB HL, except one that may be 25 dB HL)

• Native English speakers

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• Hearing Aid Program
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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	60 minutes
Secondary	Sound Quality: Music Feature across Manufacturers	Across hearing aid manufacturers, the mean sound quality with the music feature activated will be compared.	60 minutes
Secondary	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.	60 minutes