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

Vocal Fold Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410797
• Other study ID #: PRO17100675
• Status: Completed
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: December 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Atrophy
• Atrophy of Vocal Cord
• Disease
• Polyps
• Vocal Cord Cyst
• Vocal Cord Polyp
• Vocal Fold Polyp
• Voice and Resonance Disorders
• Voice Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Jacqueline Gartner-Schmidt

Country where clinical trial is conducted

United States, 

Outcome

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