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Clinical Trials/NCT03410797
NCT03410797
Completed
N/A

Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders

Jacqueline Gartner-Schmidt1 site in 1 country11 target enrollmentJune 19, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Voice and Resonance Disorders
Sponsor
Jacqueline Gartner-Schmidt
Enrollment
11
Locations
1
Primary Endpoint
Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Current semi-occluded vocal tract therapies limit the type of vocalizations that can be produced to single vowels, which does not promote learning of the healthy voice behavior in connected speech or generalization to conversation. However, recent preliminary results using a semi-occluded mask indicate that the use of certain mask port diameters may allow for natural speech production while increasing supraglottal pressure and impedance, and thereby result in elicitation of voice with increased efficiency. In addition, the use of a semi-occluded mask provides the possibility for a better transition from phonating single phonemes in therapy to training the target therapy techniques in connected speech.

Detailed Description

Treatment of voice disorders varies but often involves voice therapy and/or surgical intervention. Voice therapy, a non-invasive behavioral treatment for voice disorders, helps patients develop beneficial voice habits, prevents recurrence of voice disorders, and facilitates long-lasting vocal improvement. Many voice therapy techniques involve a semi-occluded vocal tract (SOVT). SOVT treatment is often characterized by sustained (straw phonation, voiced fricatives, nasals), oral oscillatory (lip buzzes, tongue trills, raspberries) or transitory phonation (plosives and glides). Straw phonation therapy, one of the most utilized SOVT methods, was first proposed in 1904 and involved phonating at different pitches into small glass tubes with varying diameters and lengths providing simultaneous semi-occlusion and extension of the vocal tract. Voice therapy exercises involving voice production with a semi-occluded and sometimes lengthened vocal tract have demonstrated improved vocal efficiency and loudness, reduced mechanical trauma to the vocal fold mucosa, and improved source-filter interaction.Our group recently developed a semi-occluded facemask for use in patients with and without voice disorders. Recent preliminary results using this semi-occluded facemask indicated that the use of a certain mask port diameters may elicit voice with increased efficiency. A study of 5 participants without voice disorders revealed that a mask occlusion diameter of 6.4 and 3.2 mm resulted in improved vocal efficiency. A study of the immediate effects of a semi-occluded facemask in 20 patients with voice disorders revealed that occlusions diameters of 9.6, 6.4, and 3.2 mm all resulted in significant improvements in acoustic and aerodynamic voice outcomes.

Registry
clinicaltrials.gov
Start Date
June 19, 2018
End Date
December 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Jacqueline Gartner-Schmidt
Responsible Party
Sponsor Investigator
Principal Investigator

Jacqueline Gartner-Schmidt

Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • age 18 to 60
  • diagnosed with vocal fold lesion or polyp or cyst or atrophy or other voice condition (such as muscle tension dysphonia)
  • recommended for voice therapy as treatment for voice disorder

Exclusion Criteria

  • Current smoker (greater than 5 cigarettes/week)

Outcomes

Primary Outcomes

Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy

Time Frame: Baseline and approximately 6-8 weeks later; after completion of voice therapy

VHI-10 is a 10 item, self reported, voice related outcome related to an individual's perception of their vocal quality and how it impacts their life. (Voice Handicap Index) Scale scores range from 0-40 where higher scores correspond to a worse vocal quality.

Secondary Outcomes

  • Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity)(Baseline and approximately 6-8 weeks later; after completion of voice therapy)
  • Change From Baseline in Mean Airflow in Milliliters (ml) During Reading of Standardized Paragraph(Baseline and approximately 6-8 weeks later; after completion of voice therapy)
  • Change From Baseline in Mean Vocal Intensity (dB)(Baseline and approximately 6-8 weeks later; after completion of voice therapy)
  • Change From Baseline in Cepstral Peak Prominence (dB)(Baseline and approximately 6-8 weeks later; after completion of voice therapy)
  • Change in the Number of Breaths Taken During Reading of Standardized Paragraph(Baseline to post treatment)

Study Sites (1)

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