- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05220982
Improving Efficacy of Voice Therapy Concepts Via Telepractice and Mobile App Technology
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth U Grillo, Ph.D.
- Phone Number: 6104362132
- Email: egrillo@wcupa.edu
Study Locations
-
-
Pennsylvania
-
West Chester, Pennsylvania, United States, 19383
- Recruiting
- Elizabeth Grillo
-
Contact:
- Elizabeth U Grillo, Ph.D.
- Phone Number: 610-436-2132
- Email: egrillo@wcupa.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Vocally healthy student in a bachelor of education program with student teaching planned for spring
- Professional teacher who is currently working as a teacher with voice complaints, but has not sought help for the complaints
- Owner of either an android or iOS smartphone or tablet.
Exclusion Criteria:
- Not a student teacher
- Not a professional teacher.
- Does not own a smartphone.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Conversation Training Therapy
|
Training clear speech in conversation with new vs old voice.
Training will occur over four weekly synchronous telepractice sessions.
Each session lasts 45-60 minutes.
The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention.
Participants will use the EMI platform to practice voice targets three times a day.
|
Experimental: Global Voice Prevention and Therapy Model
|
Training of four new voices (i.e., resonant voice in connected speech, falsetto for quiet talking, oral twang for talking over noise, and belt for healthy yelling) defined and trained by the anatomy and physiology of the system (i.e., Estill Voice Training's Figures).
Training occurs in a bottom-up speech hierarchy with new vs other or old voice at each step.
Additional methods are used in asynchronous telepractice to support the new voices during week 1 (e.g., vocal hygiene and education).
Training will occur over three weekly synchronous telepractice sessions.
Each session lasts 45-60 minutes.
The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention.
Participants will use the EMI platform to practice voice targets three times a day.
|
Experimental: Modified Conversation Training Therapy
|
Training clear speech in conversation with no use of new vs old voice.
Training will occur over four weekly synchronous telepractice sessions.
Each session lasts 45-60 minutes.
The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention.
Participants will use the EMI platform to practice voice targets three times a day.
|
Experimental: Modified Global Voice Prevention and Therapy Model
|
Training of a new resonant voice in connected speech defined and trained by the anatomy and physiology of the system (i.e., Estill Voice Training's Figures).
Training occurs in a bottom-up speech hierarchy with no use of new vs old voice.
Additional methods are used in asynchronous telepractice to support the new voices during week 1 (e.g., vocal hygiene and education).
Training will occur over three weekly synchronous telepractice sessions.
Each session lasts 45-60 minutes.
The ecological momentary intervention (EMI) platform (app, server, web portal) will reflect the goals of the intervention.
Participants will use the EMI platform to practice voice targets three times a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Voice Handicap Index 10
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 4 in the PM for a 5 day period via the VoiceEvalU8 app.
|
The VHI-10 is a client reported outcome measure related to voice impact on quality of life across 10 questions.
Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 4 in the PM for a 5 day period via the VoiceEvalU8 app.
|
Change in Vocal Fatigue Index (VFI) factor 1 and 2
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 5 in the PM for a 5 day period via the VoiceEvalU8 app.
|
The VFI is a client reported outcome measure related to tiredness and avoidance of voice in factor 1 and physical voice discomfort in factor 2. Factor 1 has 11 questions and factor 2 has 5 questions.
Each question is rated on a scale from 0-4 with 0 as never, 1 as almost never, 2 as sometimes, 3 as almost always, and 4 as always.
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and once weekly for 15 weeks in spring. Captured on day 5 in the PM for a 5 day period via the VoiceEvalU8 app.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fundamental Frequency
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Fundamental frequency will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Change in Jitter%
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Jitter% will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Change in noise-to-harmonic ratio
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Noise-to-harmonic ratio will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Change in cepstral peak prominence
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Change in smoothed cepstral peak prominence
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Smoothed cepstral peak prominence will be measured during 3 trials of 5-sec sustained /a/s, the phrase, "we were away a year ago," and a 15-sec connected speech sample.
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Change in acoustic voice quality index
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Acoustic voice quality index will be measured during 1 trial of the 5-sec sustained /a/ and the phrase, "we were away a year ago,"
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured twice a day in AM and PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Change in Borg Category Ratio (CR)10 scale for vocal effort
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.
|
The Borg CR10 scale rates vocal effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Change in Borg Category Ratio (CR)10 scale for mental effort
Time Frame: One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.
|
The Borg CR10 scale rates mental effort on a scale from 0-10 with 0 as no effort and 10 as maximum effort.
|
One time at pre & one time at post condition in fall (4 weeks between pre and post) and weekly for 15 weeks in spring. Captured once a day in PM sessions during a 5 day period via the VoiceEvalU8 app.
|
Student researcher (SR) voice therapy satisfaction surveys
Time Frame: Collected immediately after intervention in the fall via Qualtrics online software.
|
The voice therapy satisfaction survey will rate the student researchers' (SR) perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with 1 as strongly disagree and 5 as strongly agree. There are also some open ended responses. The SR survey has 17 questions. |
Collected immediately after intervention in the fall via Qualtrics online software.
|
Participant voice therapy satisfaction surveys
Time Frame: Collected immediately after intervention in the fall via Qualtrics online software.
|
The voice therapy satisfaction surveys will rate the participants' perceptions after completing the voice therapy conditions. The questions are rated on a scale from 1-5 with1 as strongly disagree and 5 as strongly agree. There are also some open ended responses. The participant survey has 12 questions. |
Collected immediately after intervention in the fall via Qualtrics online software.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elizabeth U Grillo, Ph.D., West Chester University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R15DC019954 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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