NCT05336747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1.9 years

First QC Date

April 4, 2022

Last Update Submit

June 8, 2024

Conditions

Keywords

cochlear implantsvoice lessons

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • Change in Auditory Skills

    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

    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

    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 Outcomes (10)

  • Participation motivation, experience, and goals

    Up to 14 weeks

  • Engagement of the participants

    Up to 12 weeks

  • Changes in Vocal Skills of Participants

    Up to 12 weeks

  • Changes in Vocal Confidence

    Change between 1 week post voice lessons and 3 months post voice lessons

  • Change in Goldsmiths Musical Sophistication Index (Gold MSI)

    Change between 1 week post voice lessons and 3 months post voice lessons

  • +5 more secondary outcomes

Study Arms (2)

Voice Lessons "Here, My Voice 2" Program

EXPERIMENTAL

Voice Lessons "Here, My Voice 2" Program

Behavioral: Voice lessons

Voice Lessons "Here, My Voice 3" Program

EXPERIMENTAL

Voice Lessons "Here, My Voice 3" Program

Behavioral: Voice lessons

Interventions

Voice lessonsBEHAVIORAL

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.

Voice Lessons "Here, My Voice 2" ProgramVoice Lessons "Here, My Voice 3" Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juri Hwang

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Practice

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 20, 2022

Study Start

April 21, 2022

Primary Completion

March 14, 2024

Study Completion

March 14, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations