Vocal Fold Polyp Clinical Trial
Official title:
Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
Verified date | December 2020 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | December 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Jacqueline Gartner-Schmidt |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and approximately 6-8 weeks later; after completion of voice therapy | |
Secondary | Change From Baseline in Cepstral Peak Prominence (dB) | 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 | |
Secondary | 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. |
Baseline and approximately 6-8 weeks later; after completion of voice therapy | |
Secondary | 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. | Baseline and approximately 6-8 weeks later; after completion of voice therapy | |
Secondary | 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. | Baseline and approximately 6-8 weeks later; after completion of voice therapy | |
Secondary | 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 |
Baseline to post treatment |
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