Back to resultsTesting a Smart Phone App to Enhance Voice Therapy Adherence
Primary Purpose
Voice Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Voice therapy
Voice Therapy App
Sponsored by
About this trial
This is an interventional treatment trial for Voice Disorders focused on measuring adherence
Eligibility Criteria
Inclusion Criteria:
- Adults > 18 years
- Non-smokers
- Hearing level within normal limits
- Absence of vocal fold pathology as confirmed by MD on laryngeal examination
- Agree to avoid vocally abusive behaviors for the entirety of the study
Exclusion Criteria:
- Apple phone (iOS)
- Impaired hearing
- Uncontrolled asthma
- Smoking
- H/o vocal fold surgery
- Presence of vocal fold pathology
- Previous history of experience with VFE performance
- Non-English speaking participants
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional Voice Therapy
App Group
Arm Description
Standard of care (traditional) voice therapy.
Voice therapy using a smartphone app.
Outcomes
Primary Outcome Measures
Adherence
Number of completed home practice sessions
Secondary Outcome Measures
MPT (maximum phonation time)
Maximum phonation time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04002336
Brief Title
Testing a Smart Phone App to Enhance Voice Therapy Adherence
Official Title
Testing a Smart Phone App to Enhance Voice Therapy Adherence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vrushali Angadi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current project is designed as phase 1 study conducted to improve/enhance normal voice. Fifteen Thirty non-treatment seeking individuals, with no identifiable vocal pathology on laryngeal examination, will be randomized to one of two groups; 1) Voice therapy delivery without App (control/standard of care), 2) Voice therapy delivery with app (experimental). Participants in both groups will attend weekly voice therapy sessions (for 6 weeks) with the PI and Co- I (Joseph Stemple). Control group participants will be provided with an audio file of the exercises, and an exercise log sheet to track progress. Experimental group participants will use the smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track. Three-wave surveys will be conducted at the baseline, four weeks and 6 weeks after the intervention. Other data sources include study administration, exercise logs, app data, and clinical assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Disorders
Keywords
adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-blinded to primary outcome measure
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Voice Therapy
Arm Type
Active Comparator
Arm Description
Standard of care (traditional) voice therapy.
Arm Title
App Group
Arm Type
Experimental
Arm Description
Voice therapy using a smartphone app.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Voice therapy
Other Intervention Name(s)
Vocal Function Exercises
Intervention Description
Traditional method of voice therapy
Intervention Type
Behavioral
Intervention Name(s)
Voice Therapy App
Other Intervention Name(s)
Vocal Function Exercises
Intervention Description
Smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track.
Primary Outcome Measure Information:
Title
Adherence
Description
Number of completed home practice sessions
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
MPT (maximum phonation time)
Description
Maximum phonation time
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults > 18 years
Non-smokers
Hearing level within normal limits
Absence of vocal fold pathology as confirmed by MD on laryngeal examination
Agree to avoid vocally abusive behaviors for the entirety of the study
Exclusion Criteria:
Apple phone (iOS)
Impaired hearing
Uncontrolled asthma
Smoking
H/o vocal fold surgery
Presence of vocal fold pathology
Previous history of experience with VFE performance
Non-English speaking participants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vrushali Angadi
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Testing a Smart Phone App to Enhance Voice Therapy Adherence
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