Muscle Tension Dysphonia Clinical Trial
The purposes of the proposed study are: a) to determine whether Flow Phonation can decrease Laryngeal Resistance (Rlaw) in patients with Muscle Tension Dysphonia (MTD); and b)establish the relationship between changes in measures of Rlaw and phonatory airflow to endoscopic, perceptual, acoustic, and handicap assessment ratings. MTD can have a debilitating effect on individuals who rely on their voices the most—teachers, preachers,salespeople, singers—costing them time, money, and even their jobs. It can lead to vocal fatigue, pain, and complete loss of voice. While treatments have emerged with some promising effects, no treatments have proven to have long-term benefits to all patients. Our preliminary data demonstrate Flow Phonation training resulted in significant decreases in Laryngeal Resistance to phonatory airflow with associated improvements in voice quality and voice handicap ratings. Sample size for our pilot study was small; no control group was utilized; and outcome measures were limited. In the proposed investigation, a larger sample will be obtained, a control group of participants receiving only Vocal Hygiene Training will be used for comparison during the first 3 weeks, and a wider range of outcome measures will be included over a longer period of time (1 year).
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Rlaw greater than 1 standard deviation above or below mean - Voice Handicap Index of greater than 18 - CAPE-V severity of 20 or greater - willing to sign informed consent - women must not have experienced menopause or be pregnant Exclusion Criteria: - organic lesion of the vocal folds - history of neurologic disease - history of head and neck cancer - pulmonary disease |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Central Arkansas | Conway | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Central Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Laryngeal Airway Resistance (Rlaw) Change Over Time | Measured using the KayPENTAX Phonatory Aerodynamic System during a voice efficiency task (i.e., repeating "apapapapapapapa." | 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months | No |
Secondary | Voice Handicap Index (VHI) | The Voice Handicap Index is a 30 item questionnaire to assess the patient's perception of the impact of their voice on their quality of life and daily functioning. | 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months | No |
Secondary | Consensus Auditory Perceptual Evaluation - Voice | The CAPE-V is a perceptual measure of voicing made by the clinician to rate the patient's vocal quality on a 100 mm line scale. | 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months | No |
Secondary | Noise-to-Harmonic Ratio | The KayPENTAX Computerized Speech Lab will be used to record and analyze sustained phonation (AH) and provide a measure of noise to harmonic ratio. | 3 weeks, 6 weeks, 12 weeks, 3 months, 12 months | No |
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