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Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia

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ClinicalTrials.gov Identifier: NCT01419444
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Description
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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.


Condition or disease Intervention/treatment Phase
Muscle Tension Dysphonia Behavioral: Airflow Exercises for Voicing Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia
Study Start Date : August 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
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Primary Outcome Measures :
  1. Mean Expiratory Airflow During Comfortable Phonation [ Time Frame: 6 weeks ]
    Measured pre- and post in liters/second using Phonatory Aerodynamic System.

  2. Voicing Efficiency [ Time Frame: 6 weeks ]
    Mean Airflow during voicing efficiency task, pa-pa-pa, using Phonatory Aerodynamic System. Measured in liters/second.


Secondary Outcome Measures :
  1. Voice Handicap Index Questionnaire [ Time Frame: 6 weeks ]
    Patient's perceived ratings of Voice Handicap on standardized, validated questionnaire.

  2. Consensus Auditory Perceptual Evaluation of Voice [ Time Frame: 6 weeks ]
    Overall perceptual rating of voice quality made by clinician on 100 point scale.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary or Secondary Muscle Tension Dysphonia

Exclusion Criteria:

  • Head and Neck Cancer
  • Spasmodic Dysphonia
  • Tremor
  • Respiratory Compromise
  • Dysphagia
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419444


Locations
United States, Arkansas
UAMS Medical Center Voice and Swallowing Clinic
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01419444     History of Changes
Other Study ID Numbers: CDHMTD2011
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013

Keywords provided by University of Arkansas:
Voice
Muscle Tension Dysphonia
Hyperfunction
Treatment

Additional relevant MeSH terms:
Dysphonia
Hoarseness
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiration Disorders
Signs and Symptoms, Respiratory