Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia

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: Muscle Tension Dysphonia
• Intervention / Treatment: Behavioral: Airflow Exercises for Voicing

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Measured pre- and post in liters/second using Phonatory Aerodynamic System.	6 weeks
Voicing Efficiency	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	Patient's perceived ratings of Voice Handicap on standardized, validated questionnaire.	6 weeks
Consensus Auditory Perceptual Evaluation of Voice	Overall perceptual rating of voice quality made by clinician on 100 point scale.	6 weeks

Collaborators and Investigators

• Sponsor: University of Arkansas

Study record dates

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: Treatment; Muscle Tension Dysphonia; Voice; Hyperfunction
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Laryngeal Diseases; Voice Disorders; Dysphonia; Hoarseness
• Other Study ID Numbers: CDHMTD2011