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Appreciation for Music Processed by Hearing Aids

Primary Purpose

Sensorineural Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hearing Aid Program
Sponsored by
Purdue University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sensorineural Hearing Loss

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Purdue UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hearing Aid Signal Processing

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sound Quality: Music Feature across Manufacturers
Across hearing aid manufacturers, the mean sound quality with the music feature activated will be compared.
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.

Full Information

First Posted
September 26, 2022
Last Updated
March 27, 2023
Sponsor
Purdue University
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1. Study Identification

Unique Protocol Identification Number
NCT05568329
Brief Title
Appreciation for Music Processed by Hearing Aids
Official Title
Appreciation for Music Processed by Hearing Aids
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aid Signal Processing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hearing Aid Program
Other Intervention Name(s)
Hearing Aid Music Feature
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sound Quality: Music Feature Activated vs. Deactivated
Description
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.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Sound Quality: Music Feature across Manufacturers
Description
Across hearing aid manufacturers, the mean sound quality with the music feature activated will be compared.
Time Frame
60 minutes
Title
Effects of Music Training
Description
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.
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal hearing (audiometric thresholds <= 20 dB HL, except one that may be 25 dB HL) Native English speakers Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Alexander, Ph.D.
Phone
17654944091
Email
alexan14@purdue.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Alexander
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Alexander, Ph.D.
Phone
765-494-4091
Email
alexan14@purdue.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Upon formal acceptance of published manuscript; to be stored indefinitely.
IPD Sharing Access Criteria
Open
IPD Sharing URL
https://purr.purdue.edu/

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Appreciation for Music Processed by Hearing Aids

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