Testing a Smart Phone App to Enhance Voice Therapy Adherence

Not Applicable

Completed

• Conditions: Voice Disorders
• Interventions: Behavioral: Voice Therapy App; Behavioral: Traditional Voice therapy

• Registration Number: NCT04002336
• Lead Sponsor: Vrushali Angadi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-06
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Last Update Submitted: 2019-06-26
• Study First Posted: 2019-06-28
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Adults > 18 years
2. Non-smokers
3. Hearing level within normal limits
4. Absence of vocal fold pathology as confirmed by MD on laryngeal examination
5. Agree to avoid vocally abusive behaviors for the entirety of the study

Exclusion Criteria

1. Apple phone (iOS)
2. Impaired hearing
3. Uncontrolled asthma
4. Smoking
5. H/o vocal fold surgery
6. Presence of vocal fold pathology
7. Previous history of experience with VFE performance
8. Non-English speaking participants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
App Group	Voice Therapy App	Voice therapy using a smartphone app.
Traditional Voice Therapy	Traditional Voice therapy	Standard of care (traditional) voice therapy.

Primary Outcome Measures

Name	Time	Method
Adherence	6 weeks	Number of completed home practice sessions

Secondary Outcome Measures

Name	Time	Method
MPT (maximum phonation time)	6 weeks	Maximum phonation time

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States