Testing a Smart Phone App to Enhance Voice Therapy Adherence

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 30, 2018

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Traditional Voice Therapy
    • Standard of care (traditional) voice therapy.
  • Experimental: App Group
    • Voice therapy using a smartphone app.

Clinical Trial Outcome Measures

Primary Measures

  • Adherence
    • Time Frame: 6 weeks
    • Number of completed home practice sessions

Secondary Measures

  • MPT (maximum phonation time)
    • Time Frame: 6 weeks
    • Maximum phonation time

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Vrushali Angadi
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Vrushali Angadi, Assistant Professor – University of Kentucky
  • Overall Official(s)
    • Vrushali Angadi, Principal Investigator, University of Kentucky

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