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OpenTrials
Completed

NCT Number: NCT04002336

Testing a Smart Phone App to Enhance Voice Therapy Adherence

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional Voice therapy

Behavioral

Traditional method of voice therapy

Other names: Vocal Function Exercises

Voice Therapy App

Behavioral

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.

Other names: Vocal Function Exercises

Primary outcomes

  1. Adherence

    Time frame: 6 weeks

    Number of completed home practice sessions

Secondary outcomes

  1. MPT (maximum phonation time)

    Time frame: 6 weeks

    Maximum phonation time

Sponsors and collaborators

Lead sponsor

Vrushali Angadi

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 28, 2019
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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