Clinical trial NCT03410797: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy
timeFrame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
Secondary outcomes:
measure: Change From Baseline in Cepstral Peak Prominence (dB)
timeFrame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
measure: Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity)
timeFrame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
measure: Change From Baseline in Mean Airflow in Milliliters (ml) During Reading of Standardized Paragraph
timeFrame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
measure: Change From Baseline in Mean Vocal Intensity (dB)
timeFrame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
measure: Change in the Number of Breaths Taken During Reading of Standardized Paragraph
timeFrame: Baseline to post treatment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References: