Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Muscle Tension Dysphonia |
Behavioral: Airflow Exercises for Voicing |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia |
- Mean Expiratory Airflow During Comfortable Phonation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Measured pre- and post in liters/second using Phonatory Aerodynamic System.
- Voicing Efficiency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Mean Airflow during voicing efficiency task, pa-pa-pa, using Phonatory Aerodynamic System. Measured in liters/second.
- Voice Handicap Index Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Patient's perceived ratings of Voice Handicap on standardized, validated questionnaire.
- Consensus Auditory Perceptual Evaluation of Voice [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Overall perceptual rating of voice quality made by clinician on 100 point scale.
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primary or Secondary Muscle Tension Dysphonia
Exclusion Criteria:
- Head and Neck Cancer
- Spasmodic Dysphonia
- Tremor
- Respiratory Compromise
- Dysphagia
Contacts and Locations| Contact: Gary H McCullough, PhD | 501-852-7886 | gmccullough@uca.edu |
| Contact: Amy Chandler, MS | 501-686-7802 | AEChandler@uams.edu |
| United States, Arkansas | |
| UAMS Medical Center Voice and Swallowing Clinic | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Gary H McCullough, PhD 501-852-7886 gmccullough@uca.edu | |
| Contact: Amy Chandler, MS 501-686-7802 AEChandler@uams.edu | |
More Information
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01419444 History of Changes |
| Other Study ID Numbers: | CDHMTD2011 |
| Study First Received: | August 16, 2011 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: UAMS Institutional Review Board |
Keywords provided by University of Arkansas:
|
Voice Muscle Tension Dysphonia Hyperfunction Treatment |
Additional relevant MeSH terms:
|
Dysphonia Voice Disorders Laryngeal Diseases Respiratory Tract Diseases |
Otorhinolaryngologic Diseases Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013