Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia

NCT01419444 | Completed Phase 1 DMC

• 1 other identifier: CDHMTD2011
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Tension Dysphonia

Keywords

Voice; Muscle Tension Dysphonia; Hyperfunction; Treatment

Outcome Measures

Primary Outcomes (2)

• Mean Expiratory Airflow During Comfortable Phonation

  Measured pre- and post in liters/second using Phonatory Aerodynamic System.

  6 weeks

• Voicing Efficiency

  Mean Airflow during voicing efficiency task, pa-pa-pa, using Phonatory Aerodynamic System. Measured in liters/second.

  6 weeks

Secondary Outcomes (2)

• Voice Handicap Index Questionnaire

  6 weeks

• Consensus Auditory Perceptual Evaluation of Voice

  6 weeks

Study Arms (2)

Traditional, Onsite Treatment

ACTIVE COMPARATOR

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

Telemedicine Treatment

EXPERIMENTAL

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

Interventions

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.

Telemedicine Treatment; Traditional, Onsite Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary or Secondary Muscle Tension Dysphonia

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

UAMS Medical Center Voice and Swallowing Clinic

Little Rock, Arkansas, 72205, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 18, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 18, 2013

Record last verified: 2013-12

Locations

US (1)