Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia

December 17, 2013 updated by: University of Arkansas

The purpose of this research is to determine whether treatment of voice disorders can be provided just as effectively using telemedicine as it can using on-site, traditional therapy. An exercise protocol for improving airflow with voicing has been demonstrated to be effective in a prior UAMS investigation (Protocol 107454). These exercises are used as part of the normal clinic routine at UAMS working with individuals with voice problems. The three exercises used are: gargling with and without voicing; cup bubble blowing with and without voicing; and, stretch and flow exercises, which involves the use of a piece of tissue to provide visual biofeedback on the ability to use proper airflow with voicing. The purpose of the exercises is to increase airflow and breathiness in the voice and reduce muscle tension. In addition, patients will be taught to use a "confidential voice" or gentle voice during speaking.

The investigators voice patients come from all over the state and many cannot return for regular treatment. Developing a way to provide treatment to them closer to home could greatly improve quality of care and quality of life. Twenty participants will participate for 12 sessions each. All participants will be evaluated at UAMS before and after treatment as part of standard care and will, upon consent, be randomized to receive treatment via telemedicine at an AHEC site or at UAMS Medical Center. Homework will be provided along with log sheets. Results of airflow measures using an airflow-recording device (Viasys, KAY/PENTAX) pre- and post treatment will determine whether telemedicine results are equal to results of traditional, on-site treatment. The investigators hypothesize that results from treatment using telemedicine will be equivalent to results for onsite, traditional treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • UAMS Medical Center Voice and Swallowing Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary or Secondary Muscle Tension Dysphonia

Exclusion Criteria:

  • Head and Neck Cancer
  • Spasmodic Dysphonia
  • Tremor
  • Respiratory Compromise
  • Dysphagia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional, Onsite Treatment
Onsite treatment using airflow exercises. Patients will receive face-to-face treatment with the research speech pathologist two times per week.
Behavioral: Airflow Exercises for Voicing
Gargling, Cup Bubble Blowing, and Stretch and Flow Exercises will be taught to reduce laryngeal closure and improve airflow through the glottis during voicing.
Experimental: Telemedicine Treatment
Participants will receive treatment via telemedicine at select AHEC sites around the state of Arkansas. Treatments will occur twice per week with the research speech pathologist.
Behavioral: Airflow Exercises for Voicing
Gargling, Cup Bubble Blowing, and Stretch and Flow Exercises will be taught to reduce laryngeal closure and improve airflow through the glottis during voicing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Expiratory Airflow During Comfortable Phonation
Time Frame: 6 weeks
Measured pre- and post in liters/second using Phonatory Aerodynamic System.
6 weeks
Voicing Efficiency
Time Frame: 6 weeks
Mean Airflow during voicing efficiency task, pa-pa-pa, using Phonatory Aerodynamic System. Measured in liters/second.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice Handicap Index Questionnaire
Time Frame: 6 weeks
Patient's perceived ratings of Voice Handicap on standardized, validated questionnaire.
6 weeks
Consensus Auditory Perceptual Evaluation of Voice
Time Frame: 6 weeks
Overall perceptual rating of voice quality made by clinician on 100 point scale.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHMTD2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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