- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05336747
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
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
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Hearing Loss
-
MED-EL Elektromedizinische Geräte GesmbHCompletedHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Unilateral | Hearing Loss, MixedAustria, Germany, United Kingdom
-
Oticon MedicalCompletedEar Diseases | Hearing Loss, Conductive | Hearing Loss Mixed | Hearing Disability | Conductive Hearing Loss | Conductive Hearing Loss, Bilateral | Conductive Hearing Loss, UnilateralUnited Kingdom
-
Oticon MedicalNot yet recruitingSensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound
-
University of California, San FranciscoPatient-Centered Outcomes Research InstituteRecruitingHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Noise-Induced | Hearing Loss, Unilateral | Hearing Loss, Mixed | Hearing Disorders in ChildrenUnited States
-
Manchester University NHS Foundation TrustUniversity of ManchesterCompletedCochlear Hearing Loss | Sensorineural Hearing Loss, BilateralUnited Kingdom
-
Truway Health, Inc.Enrolling by invitationSensorineural Hearing Loss | Tinnitus | Sudden Hearing Loss | Acoustic Trauma | Inner Ear Injury | Noise-Induced Hearing Loss | Vestibular DysfunctionUnited States
-
Envoy Medical CorporationActive, not recruitingSensorineural Hearing Loss | Sensorineural Hearing Loss (Disorder) | Sensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound | Sensori-Neural DeafnessUnited States
-
Oticon MedicalCompletedConductive Hearing Loss | Conductive and Sensori-neural Hearing Loss in the Same Ear | Unilateral, Profound Sensori-neural Hearing LossUnited States
-
Frequency TherapeuticsCompletedHearing Loss, Sensorineural | Presbycusis | Noise Induced Hearing Loss | Sudden Hearing LossUnited States
-
Frequency TherapeuticsCompletedHearing Loss, Sensorineural | Noise Induced Hearing Loss | Sudden Hearing LossUnited States
Clinical Trials on Voice lessons
-
University of RochesterEastman Performing Arts Medicine Center; University of Rochester Aging Institute and other collaboratorsCompletedMild Cognitive Impairment (MCI) | Memory Decline | Memory Disorders, Age RelatedUnited States
-
University of Vic - Central University of CataloniaNot yet recruitingPhysical Activity | Executive FunctionSpain
-
Fundacion para la Investigacion Biomedica del Hospital...Withdrawn
-
Istituti Clinici Scientifici Maugeri SpARecruiting
-
Mazonson & Santas Inc.Completed
-
Istituto Scientifico Romagnolo per lo Studio e...Active, not recruitingQuality of Life | Fatigue | Radiotherapy; Complications | Physiological Stress | Female Breast CancerItaly
-
University of IoanninaCompletedEmergencies | Child, Only | Head Injury | Trauma-related Wound | Nose Bleed | ChokingGreece
-
Hospital Severo OchoaCompletedEmotional IntelligenceSpain
-
Peking University Sixth HospitalCompleted
-
KDH Research & CommunicationNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruitingMenopause | Health | Community Health Workers | African Americans | Women | Hispanic or LatinoUnited States