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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Voice Lessons "Here, My Voice 2" Program
Behavioral: Voice lessons
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
Behavioral: Voice lessons
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UP-22-00164

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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