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Here, My Voice 2 Voice Lessons Pilot (HMV2)

Primary Purpose

Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Voice lessons
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hearing Loss focused on measuring cochlear implants, voice lessons

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Voice Lessons

Arm Description

Voice Lessons

Outcomes

Primary Outcome Measures

Change in Vocal Confidence
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 in Goldsmiths Musical Sophistication Index (Gold MSI)
The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills
Change in Quality of Life in Neurological Disorders (Neuro-QoL) Questionnaire
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 in Auditory Skills
Speech and music perceptual abilities via TeamHearing software.
Change in Vocal Skills of Audio Recordings of Participants
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 in Self Esteem
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).

Secondary Outcome Measures

Participation motivation, experience, and goals
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.
Engagement of the participants
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.
Changes in Vocal Skills of Participants
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.
Changes in Vocal Confidence
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 in Goldsmiths Musical Sophistication Index (Gold MSI)
The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills
Change in Quality of Life in Neurological Disorders (Neuro-QoL) Questionnaire
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 in Auditory Skills
Speech and music perceptual abilities via TeamHearing software
Change in Vocal Skills of Audio Recordings of Participants
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 in Self Esteem
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).
Changes in Music Experience UCMLQ Questionnaire
University of Canterbury Music Listening Questionnaire (UCMLQ) questionnaire will measure participants music experience with Hearing Aids or/and Cochlear Implants

Full Information

First Posted
April 4, 2022
Last Updated
April 20, 2023
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT05336747
Brief Title
Here, My Voice 2 Voice Lessons Pilot
Acronym
HMV2
Official Title
Here, My Voice 2 - Voice Lessons Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
cochlear implants, voice lessons

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Voice Lessons
Arm Type
Experimental
Arm Description
Voice Lessons
Intervention Type
Behavioral
Intervention Name(s)
Voice lessons
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Vocal Confidence
Description
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.
Time Frame
Change between baseline and 1 week post voice lessons
Title
Change in Goldsmiths Musical Sophistication Index (Gold MSI)
Description
The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills
Time Frame
Change between baseline and 1 week post voice lessons
Title
Change in Quality of Life in Neurological Disorders (Neuro-QoL) Questionnaire
Description
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.
Time Frame
Change between baseline and 1 week post voice lessons
Title
Change in Auditory Skills
Description
Speech and music perceptual abilities via TeamHearing software.
Time Frame
Change between baseline and 1 week post voice lessons
Title
Change in Vocal Skills of Audio Recordings of Participants
Description
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).
Time Frame
Change between baseline and 1 week post voice lessons
Title
Change in Self Esteem
Description
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).
Time Frame
Change between baseline and 1 week post voice lessons
Secondary Outcome Measure Information:
Title
Participation motivation, experience, and goals
Description
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.
Time Frame
Up to 14 weeks
Title
Engagement of the participants
Description
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.
Time Frame
Up to 12 weeks
Title
Changes in Vocal Skills of Participants
Description
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.
Time Frame
Up to 12 weeks
Title
Changes in Vocal Confidence
Description
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.
Time Frame
Change between 1 week post voice lessons and 3 months post voice lessons
Title
Change in Goldsmiths Musical Sophistication Index (Gold MSI)
Description
The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills
Time Frame
Change between 1 week post voice lessons and 3 months post voice lessons
Title
Change in Quality of Life in Neurological Disorders (Neuro-QoL) Questionnaire
Description
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.
Time Frame
Change between 1 week post voice lessons and 3 months post voice lessons
Title
Change in Auditory Skills
Description
Speech and music perceptual abilities via TeamHearing software
Time Frame
Change between 1 week post voice lessons and 3 months post voice lessons
Title
Change in Vocal Skills of Audio Recordings of Participants
Description
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)
Time Frame
Change between 1 week post voice lessons and 3 months post voice lessons
Title
Change in Self Esteem
Description
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).
Time Frame
Change between 1 week post voice lessons and 3 months post voice lessons
Title
Changes in Music Experience UCMLQ Questionnaire
Description
University of Canterbury Music Listening Questionnaire (UCMLQ) questionnaire will measure participants music experience with Hearing Aids or/and Cochlear Implants
Time Frame
Change between baseline and 1 week post voice lessons

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juri Hwang
Phone
213-740-3159
Email
jurihwan@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juri Hwang
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juri Hwang
Phone
213-740-3159
Email
jurihwan@usc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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