Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia

Muscle Tension Dysphonia Clinical Trial

Official title:

Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419444
• Other study ID #: CDHMTD2011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 16, 2011
• Last updated: December 17, 2013
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: UAMS Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Primary or Secondary Muscle Tension Dysphonia

Exclusion Criteria:

• Head and Neck Cancer

• Spasmodic Dysphonia

• Tremor

• Respiratory Compromise

• Dysphagia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysphonia
• Hoarseness
• Muscle Tension Dysphonia

Intervention

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.

Locations

Country	Name	City	State
United States	UAMS Medical Center Voice and Swallowing Clinic	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Expiratory Airflow During Comfortable Phonation	Measured pre- and post in liters/second using Phonatory Aerodynamic System.	6 weeks	No
Primary	Voicing Efficiency	Mean Airflow during voicing efficiency task, pa-pa-pa, using Phonatory Aerodynamic System. Measured in liters/second.	6 weeks	No
Secondary	Voice Handicap Index Questionnaire	Patient's perceived ratings of Voice Handicap on standardized, validated questionnaire.	6 weeks	No
Secondary	Consensus Auditory Perceptual Evaluation of Voice	Overall perceptual rating of voice quality made by clinician on 100 point scale.	6 weeks	No