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

December 10, 2020 updated by: Jacqueline Gartner-Schmidt
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Voice Disorder Requiring Voice Therapy
Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment.
Device: Inclusion of semi-occluded mask in voice therapy
Patients will be given a facemask with a semi-occlusion (SOMask) for use during in person voice therapy and for use at home therapy practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and approximately 6-8 weeks later; after completion of voice therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Cepstral Peak Prominence (dB)
Time Frame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
CPP is an objective evaluation of voice recordings through specialized vocal analysis software.
Baseline and approximately 6-8 weeks later; after completion of voice therapy
Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity)
Time Frame: Baseline and approximately 6-8 weeks later; after completion of voice therapy

CSID is an objective evaluation of voice recordings through specialized vocal analysis software.

The CSID is a multifactorial estimate of vocal severity that correlates with the labeled visual analog scale for severity (in %). Normal cutoff range is from 19-24. Values outside of this range are considered to have varying degrees of dysphonia. The values are captured using specialized voice analysis equipment and analyzed using the specialized CSID software.

Depending on the voice disorder, CSID can be calculated as both negative and positive integers with no true boundaries.
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
Time Frame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
mean airflow will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
Baseline and approximately 6-8 weeks later; after completion of voice therapy
Change From Baseline in Mean Vocal Intensity (dB)
Time Frame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
mean vocal intensity will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
Baseline and approximately 6-8 weeks later; after completion of voice therapy
Change in the Number of Breaths Taken During Reading of Standardized Paragraph
Time Frame: Baseline to post treatment

Numeric value of the number of breaths needed to complete the reading of a paragraph.

Values are positive integers
Baseline to post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacqueline Gartner-Schmidt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO17100675

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Any data shared would be completely de-identified. Currently there is no plan to share information at this time.

IPD Sharing Access Criteria

additional researchers may receive de-identified information only if a data use agreement has been executed.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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