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Completed

NCT Number: NCT01419444

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UAMS Medical Center Voice and Swallowing Clinic

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary or Secondary Muscle Tension Dysphonia

Exclusion criteria

  • Head and Neck Cancer
  • Spasmodic Dysphonia
  • Tremor
  • Respiratory Compromise
  • Dysphagia

Treatment and study plan

Airflow Exercises for Voicing

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 18, 2011
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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