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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05336747
Other study ID # UP-22-00164
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 21, 2022
Est. completion date March 14, 2024

Study information

Verified date June 2024
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 14, 2024
Est. primary completion date March 14, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Southern California Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 between baseline and 1 week post voice lessons
Primary Change in Goldsmiths Musical Sophistication Index (Gold MSI) The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills Change between baseline and 1 week post voice lessons
Primary 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 between baseline and 1 week post voice lessons
Primary Change in Auditory Skills Speech and music perceptual abilities via TeamHearing software. Change between baseline and 1 week post voice lessons
Primary 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 between baseline and 1 week post voice lessons
Primary 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). Change between baseline and 1 week post voice lessons
Secondary 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. Up to 14 weeks
Secondary 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. Up to 12 weeks
Secondary 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. Up to 12 weeks
Secondary 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 between 1 week post voice lessons and 3 months post voice lessons
Secondary Change in Goldsmiths Musical Sophistication Index (Gold MSI) The Goldsmiths Musical Sophistication Index measures musical attitudes, behaviours, and skills Change between 1 week post voice lessons and 3 months post voice lessons
Secondary 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 between 1 week post voice lessons and 3 months post voice lessons
Secondary Change in Auditory Skills Speech and music perceptual abilities via TeamHearing software Change between 1 week post voice lessons and 3 months post voice lessons
Secondary 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 between 1 week post voice lessons and 3 months post voice lessons
Secondary 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). Change between 1 week post voice lessons and 3 months post voice lessons
Secondary 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 Change between baseline and 1 week post voice lessons
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