Hearing LossHMV2NCT05336747
Here, My Voice 2 Voice Lessons Pilot
A study testing Voice lessons in people with Hearing Loss, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Voice lessons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 14 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: 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.
- Conditions
- Hearing Loss
- Being tested
- Voice lessons
- Keywords
- cochlear implants, voice lessons
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice lessonsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Voice Lessons "Here, My Voice 2" Program | Experimental | Voice Lessons "Here, My Voice 2" Program Receives: Behavioral: Voice lessons |
| Voice Lessons "Here, My Voice 3" Program | Experimental | Voice Lessons "Here, My Voice 3" Program Receives: Behavioral: Voice lessons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and 1 week post voice lessons
Change in Goldsmiths Musical Sophistication Index (Gold MSI)
The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills
Measured: Change between baseline and 1 week post voice lessons
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.
Measured: Change between baseline and 1 week post voice lessons
Change in Auditory Skills
Speech and music perceptual abilities via TeamHearing software.
Measured: Change between baseline and 1 week post voice lessons
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).
Measured: Change between baseline and 1 week post voice lessons
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).
Measured: Change between baseline and 1 week post voice lessons
Secondary outcomes (10)
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.
Measured: Up to 14 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Change between 1 week post voice lessons and 3 months post voice lessons
Change in Goldsmiths Musical Sophistication Index (Gold MSI)
The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills
Measured: Change between 1 week post voice lessons and 3 months post voice lessons
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.
Measured: Change between 1 week post voice lessons and 3 months post voice lessons
Change in Auditory Skills
Speech and music perceptual abilities via TeamHearing software
Measured: Change between 1 week post voice lessons and 3 months post voice lessons
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)
Measured: Change between 1 week post voice lessons and 3 months post voice lessons
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).
Measured: Change between 1 week post voice lessons and 3 months post voice lessons
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
Measured: Change between baseline and 1 week post voice lessons
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start21 Apr 2022
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marientina Gotsis, University of Southern California
- Investigators
- Juri Hwang, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336747
- Sponsor's protocol ID
- UP-22-00164
- Acronym
- HMV2
- Status last verified
- Jun 2024
- First submitted
- 4 Apr 2022
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Here, My Voice 2 - Voice Lessons Pilot
- ClinicalTrials.gov ID
- NCT05336747
- Acronym / sponsor ID
- HMV2 / UP-22-00164
- Conditions
- Hearing Loss
- Keywords
- cochlear implants, voice lessons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voice Lessons "Here, My Voice 2" Program | Experimental | Behavioral: Voice lessonsVoice Lessons "Here, My Voice 2" Program |
| Voice Lessons "Here, My Voice 3" Program | Experimental | Behavioral: Voice lessonsVoice Lessons "Here, My Voice 3" Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice lessons12 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. | Behavioural | Voice Lessons "Here, My Voice 2" Program, Voice Lessons "Here, My Voice 3" Program |
Primary outcome
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 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 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 in Auditory Skills
Time frame: Change between baseline and 1 week post voice lessons
Speech and music perceptual abilities via TeamHearing software.
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 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).
10 secondary outcomes
Participation motivation, experience, and goals
Time frame: Up to 14 weeks
Engagement of the participants
Time frame: Up to 12 weeks
Changes in Vocal Skills of Participants
Time frame: Up to 12 weeks
Changes in Vocal Confidence
Time frame: 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
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
Change in Auditory Skills
Time frame: 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
Change in Self Esteem
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juri Hwang principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice lessons in people with Hearing Loss, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vocal Confidence (time frame: Change between baseline and 1 week post voice lessons). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.