Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	14
Study Start Date:	August 2011
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (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 (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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:	December 17, 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 Hoarseness Voice Disorders Laryngeal Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases	Neurologic Manifestations Nervous System Diseases Signs and Symptoms Respiration Disorders Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on September 27, 2016