Testing a Smart Phone App to Enhance Voice Therapy Adherence

Voice Disorders Clinical Trial

Official title:

Testing a Smart Phone App to Enhance Voice Therapy Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002336
• Other study ID #: 44183
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: June 2019
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Voice Disorders

Intervention

Behavioral:
• Traditional Voice therapy
Traditional method of voice therapy
• Voice Therapy App
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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Vrushali Angadi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Number of completed home practice sessions	6 weeks
Secondary	MPT (maximum phonation time)	Maximum phonation time	6 weeks