Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
Primary Purpose
Voice and Resonance Disorders, Vocal Fold Polyp, Vocal Cord Cyst
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inclusion of semi-occluded mask in voice therapy
Sponsored by
About this trial
This is an interventional treatment trial for Voice and Resonance Disorders focused on measuring SOVT, semi occluded vocal tract, voice disorder, voice therapy, muscle tension dysphonia, MTD, vocal fold lesions, vocal fold atrophy
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)
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Voice Disorder Requiring Voice Therapy
Arm Description
Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment.
Outcomes
Primary Outcome Measures
Change From Baseline in VHI-10 Score After 4 Sessions 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 Outcome Measures
Change From Baseline in Cepstral Peak Prominence (dB)
CPP is an objective evaluation of voice recordings through specialized vocal analysis software.
Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity)
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.
Change From Baseline in Mean Airflow in Milliliters (ml) During Reading of Standardized Paragraph
mean airflow will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
Change From Baseline in Mean Vocal Intensity (dB)
mean vocal intensity will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
Change in the Number of Breaths Taken During Reading of Standardized Paragraph
Numeric value of the number of breaths needed to complete the reading of a paragraph.
Values are positive integers
Full Information
NCT ID
NCT03410797
First Posted
January 5, 2018
Last Updated
December 10, 2020
Sponsor
Jacqueline Gartner-Schmidt
1. Study Identification
Unique Protocol Identification Number
NCT03410797
Brief Title
Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
Official Title
Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacqueline Gartner-Schmidt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice and Resonance Disorders, Vocal Fold Polyp, Vocal Cord Cyst, Vocal Cord Polyp, Atrophy of Vocal Cord
Keywords
SOVT, semi occluded vocal tract, voice disorder, voice therapy, muscle tension dysphonia, MTD, vocal fold lesions, vocal fold atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Voice Disorder Requiring Voice Therapy
Arm Type
Other
Arm Description
Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment.
Intervention Type
Device
Intervention Name(s)
Inclusion of semi-occluded mask in voice therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy
Description
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.
Time Frame
Baseline and approximately 6-8 weeks later; after completion of voice therapy
Secondary Outcome Measure Information:
Title
Change From Baseline in Cepstral Peak Prominence (dB)
Description
CPP is an objective evaluation of voice recordings through specialized vocal analysis software.
Time Frame
Baseline and approximately 6-8 weeks later; after completion of voice therapy
Title
Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity)
Description
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.
Time Frame
Baseline and approximately 6-8 weeks later; after completion of voice therapy
Title
Change From Baseline in Mean Airflow in Milliliters (ml) During Reading of Standardized Paragraph
Description
mean airflow will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
Time Frame
Baseline and approximately 6-8 weeks later; after completion of voice therapy
Title
Change From Baseline in Mean Vocal Intensity (dB)
Description
mean vocal intensity will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
Time Frame
Baseline and approximately 6-8 weeks later; after completion of voice therapy
Title
Change in the Number of Breaths Taken During Reading of Standardized Paragraph
Description
Numeric value of the number of breaths needed to complete the reading of a paragraph.
Values are positive integers
Time Frame
Baseline to post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
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