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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
Arkansas
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Little Rock, Arkansas, United States, 72205
- UAMS Medical Center Voice and Swallowing Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Gargling, Cup Bubble Blowing, and Stretch and Flow Exercises will be taught to reduce laryngeal closure and improve airflow through the glottis during voicing.
|
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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.
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDHMTD2011
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