Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia
Primary Purpose
Muscle Tension Dysphonia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Airflow Exercises for Voicing
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Tension Dysphonia focused on measuring Voice, Muscle Tension Dysphonia, Hyperfunction, Treatment
Eligibility Criteria
Inclusion Criteria:
- Primary or Secondary Muscle Tension Dysphonia
Exclusion Criteria:
- Head and Neck Cancer
- Spasmodic Dysphonia
- Tremor
- Respiratory Compromise
- Dysphagia
Sites / Locations
- UAMS Medical Center Voice and Swallowing Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional, Onsite Treatment
Telemedicine Treatment
Arm Description
Onsite treatment using airflow exercises. Patients will receive face-to-face treatment with the research speech pathologist two times per week.
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.
Outcomes
Primary Outcome Measures
Mean Expiratory Airflow During Comfortable Phonation
Measured pre- and post in liters/second using Phonatory Aerodynamic System.
Voicing Efficiency
Mean Airflow during voicing efficiency task, pa-pa-pa, using Phonatory Aerodynamic System. Measured in liters/second.
Secondary Outcome Measures
Voice Handicap Index Questionnaire
Patient's perceived ratings of Voice Handicap on standardized, validated questionnaire.
Consensus Auditory Perceptual Evaluation of Voice
Overall perceptual rating of voice quality made by clinician on 100 point scale.
Full Information
NCT ID
NCT01419444
First Posted
August 16, 2011
Last Updated
December 17, 2013
Sponsor
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT01419444
Brief Title
Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia
Official Title
Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tension Dysphonia
Keywords
Voice, Muscle Tension Dysphonia, Hyperfunction, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional, Onsite Treatment
Arm Type
Active Comparator
Arm Description
Onsite treatment using airflow exercises. Patients will receive face-to-face treatment with the research speech pathologist two times per week.
Arm Title
Telemedicine Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Airflow Exercises for Voicing
Intervention Description
Gargling, Cup Bubble Blowing, and Stretch and Flow Exercises will be taught to reduce laryngeal closure and improve airflow through the glottis during voicing.
Primary Outcome Measure Information:
Title
Mean Expiratory Airflow During Comfortable Phonation
Description
Measured pre- and post in liters/second using Phonatory Aerodynamic System.
Time Frame
6 weeks
Title
Voicing Efficiency
Description
Mean Airflow during voicing efficiency task, pa-pa-pa, using Phonatory Aerodynamic System. Measured in liters/second.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Voice Handicap Index Questionnaire
Description
Patient's perceived ratings of Voice Handicap on standardized, validated questionnaire.
Time Frame
6 weeks
Title
Consensus Auditory Perceptual Evaluation of Voice
Description
Overall perceptual rating of voice quality made by clinician on 100 point scale.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary or Secondary Muscle Tension Dysphonia
Exclusion Criteria:
Head and Neck Cancer
Spasmodic Dysphonia
Tremor
Respiratory Compromise
Dysphagia
Facility Information:
Facility Name
UAMS Medical Center Voice and Swallowing Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia
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