Here, My Voice 2 Voice Lessons Pilot (HMV2)

June 8, 2024 updated by: Marientina Gotsis, University of Southern California

Here, My Voice 2 - Voice Lessons Pilot

Active music engagement has been shown to provide unique benefits for both pediatric and adult cochlear implant (CI) users. Here, My Voice 2 (HMV 2) project will build upon the 2021 pilot program and provide personalized voice lessons to members of the hard-of-hearing (HOH) community in order to support the (re)discovery of their voice as a tool of self-expression. Over the course of 12 weeks, participants from the HOH community will partner with students from USC's Thornton School of Music to practice expressive vocal techniques in one-on-one individual lessons. At the conclusion of the lessons, HLAA will host a communal session with a recital in which each team will present what they have worked on. Data will be collected via self-assessment surveys, vocal assessment measures, and interviews at the beginning, middle, and end of the program, as well as a 3 month follow-up. This data will be quantified/coded using qualitative coding, as appropriate, and the findings will be published in relevant conferences and journals. The data will also be used to evaluate the merits of this program to improve the format in future iterations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults, English speaking, who experience profound hearing loss and use cochlear implants or/and hearing aids.
  • Ability to use voice without discomfort and without causing any health issues.
  • Ability to commit one hour a week over a 12-week period and an additional 10 min period of daily training.

Exclusion Criteria:

  • People with medical conditions such as tracheostomy, which makes using voice difficult and potentially threatens their health
  • People taking part in other training programs for vocal, musical or auditory skills in the same time period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Voice Lessons "Here, My Voice 2" Program
12 x 60 minute one-on-one vocal training lessons, once weekly in person or over videoconferencing, and additional 60 min per week home training of vocal pitch control using an internet based vocal pitch app.
Experimental: Voice Lessons "Here, My Voice 3" Program
12 x 60 minute one-on-one vocal training lessons, once weekly in person or over videoconferencing, and additional 60 min per week home training of vocal pitch control using an internet based vocal pitch app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Vocal Confidence
Time Frame: Change between baseline and 1 week post voice lessons
Vocal confidence will be measured using a questionnaire developed by USC's Bionic Ear Lab researchers combined with Singing Voice Handicap Index (SVHI) to measure levels of self-esteem as well as physical and emotional experiences related to singing.
Change between baseline and 1 week post voice lessons
Change in Goldsmiths Musical Sophistication Index (Gold MSI)
Time Frame: Change between baseline and 1 week post voice lessons
The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills
Change between baseline and 1 week post voice lessons
Change in Quality of Life in Neurological Disorders (Neuro-QoL) Questionnaire
Time Frame: Change between baseline and 1 week post voice lessons
The specific domains assessed in Neurological Disorders (Neuro-QoL) Questionnaire will include: ability to participate in social roles and activities, positive affect and well-being, and satisfaction with social roles and activities.
Change between baseline and 1 week post voice lessons
Change in Auditory Skills
Time Frame: Change between baseline and 1 week post voice lessons
Speech and music perceptual abilities via TeamHearing software.
Change between baseline and 1 week post voice lessons
Change in Vocal Skills of Audio Recordings of Participants
Time Frame: Change between baseline and 1 week post voice lessons
Pitch matching, interval matching, and rhythm matching abilities will be rated automatically for accuracy by Praat speech analysis software and additional characteristics of vocal quality and singing accuracy (melodic contour, diction, tempo, tone, phrasing, and breath) will be rated by voice teachers on a Likert-type scale (0-5 with higher being more accurate).
Change between baseline and 1 week post voice lessons
Change in Self Esteem
Time Frame: Change between baseline and 1 week post voice lessons
The Rosenberg Self Esteem Scale is a10-item self-reported questionnaire designed to measure self-esteem. It includes 10 statements related to a person's feelings of self-worth or self-acceptance. A four-point scale ranging from "strongly agree" to "strongly disagree" is used to answer the questions (Rosenberg Self-Esteem Scale, n.d). The RSES is a reliable instrument as indicated by its Guttman scale coefficient of reproducibility of 0.92, which indicates excellent internal consistency. Test-retest reliability has correlations of 0.85 and 0.88 over a 2-week period, which indicates appropriate stability. The validity of the RSES is demonstrated by its concurrent, predictive, and constructive validity using known groups. The RSES correlates significantly with other measures of self-esteem such as the Coopersmith Self-Esteem Inventory as well as with the predicted direction of measures of depression and anxiety (Rosenberg, 2006).
Change between baseline and 1 week post voice lessons

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation motivation, experience, and goals
Time Frame: Up to 14 weeks
Semi-structured interviews will be used to assess participant motivation and quality of experience within the program. Responses will be qualitatively coded and compared from baseline to the end of the program.
Up to 14 weeks
Engagement of the participants
Time Frame: Up to 12 weeks
Voice teachers will keep a teaching log reflecting upon participants' attendance, motivation, and engagement.These notes will be compiled and coded following the program to qualitatively track vocal progress of participants throughout the study.
Up to 12 weeks
Changes in Vocal Skills of Participants
Time Frame: Up to 12 weeks
Voice teachers will keep a teaching log reflecting upon student progress and which techniques, vocal warm-ups, or other learning methods proved most effective during lessons. These notes will be compiled and coded following the program to qualitatively track vocal progress of participants throughout the study.
Up to 12 weeks
Changes in Vocal Confidence
Time Frame: Change between 1 week post voice lessons and 3 months post voice lessons
Vocal confidence will be measured using a questionnaire developed by USC's Bionic Ear Lab researchers combined with Singing Voice Handicap Index (SVHI) to measure levels of self-esteem as well as physical and emotional experiences related to singing.
Change between 1 week post voice lessons and 3 months post voice lessons
Change in Goldsmiths Musical Sophistication Index (Gold MSI)
Time Frame: Change between 1 week post voice lessons and 3 months post voice lessons
The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills
Change between 1 week post voice lessons and 3 months post voice lessons
Change in Quality of Life in Neurological Disorders (Neuro-QoL) Questionnaire
Time Frame: Change between 1 week post voice lessons and 3 months post voice lessons
The specific domains assessed in Neurological Disorders (Neuro-QoL) Questionnaire will include: ability to participate in social roles and activities, positive affect and well-being, and satisfaction with social roles and activities.
Change between 1 week post voice lessons and 3 months post voice lessons
Change in Auditory Skills
Time Frame: Change between 1 week post voice lessons and 3 months post voice lessons
Speech and music perceptual abilities via TeamHearing software
Change between 1 week post voice lessons and 3 months post voice lessons
Change in Vocal Skills of Audio Recordings of Participants
Time Frame: Change between 1 week post voice lessons and 3 months post voice lessons
Pitch matching, interval matching, and rhythm matching abilities will be rated automatically for accuracy by Praat speech analysis software and additional characteristics of vocal quality and singing accuracy (melodic contour, diction, tempo, tone, phrasing, and breath) will be rated by voice teachers on a Likert-type scale (0-5 with higher being more accurate)
Change between 1 week post voice lessons and 3 months post voice lessons
Change in Self Esteem
Time Frame: Change between 1 week post voice lessons and 3 months post voice lessons
The Rosenberg Self Esteem Scale is a10-item self-reported questionnaire designed to measure self-esteem. It includes 10 statements related to a person's feelings of self-worth or self-acceptance. A four-point scale ranging from "strongly agree" to "strongly disagree" is used to answer the questions (Rosenberg Self-Esteem Scale, n.d). The RSES is a reliable instrument as indicated by its Guttman scale coefficient of reproducibility of 0.92, which indicates excellent internal consistency. Test-retest reliability has correlations of 0.85 and 0.88 over a 2-week period, which indicates appropriate stability. The validity of the RSES is demonstrated by its concurrent, predictive, and constructive validity using known groups. The RSES correlates significantly with other measures of self-esteem such as the Coopersmith Self-Esteem Inventory as well as with the predicted direction of measures of depression and anxiety (Rosenberg, 2006).
Change between 1 week post voice lessons and 3 months post voice lessons
Changes in Music Experience UCMLQ Questionnaire
Time Frame: Change between baseline and 1 week post voice lessons
University of Canterbury Music Listening Questionnaire (UCMLQ) questionnaire will measure participants music experience with Hearing Aids or/and Cochlear Implants
Change between baseline and 1 week post voice lessons

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Juri Hwang, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Actual)

March 14, 2024

Study Completion (Actual)

March 14, 2024

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 8, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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