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Testing a Smart Phone App to Enhance Voice Therapy Adherence

NCT ID: NCT04002336

Last Updated: 2019-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2018-11-30

Brief Summary

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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

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Conditions

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Voice Disorders

Keywords

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adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single-blinded to primary outcome measure

Study Groups

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Traditional Voice Therapy

Standard of care (traditional) voice therapy.

Group Type ACTIVE_COMPARATOR

Traditional Voice therapy

Intervention Type BEHAVIORAL

Traditional method of voice therapy

App Group

Voice therapy using a smartphone app.

Group Type EXPERIMENTAL

Voice Therapy App

Intervention Type 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.

Interventions

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Traditional Voice therapy

Traditional method of voice therapy

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Vocal Function Exercises Vocal Function Exercises

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vrushali Angadi

OTHER

Sponsor Role lead

Responsible Party

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Vrushali Angadi

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vrushali Angadi

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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44183

Identifier Type: -

Identifier Source: org_study_id