An interventional study of Inclusion of semi-occluded mask in voice therapy in Voice and Resonance Disorders, Vocal Fold Polyp and Vocal Cord Cyst, sponsored by Jacqueline Gartner-Schmidt. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Jacqueline Gartner-Schmidt · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
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.
Time frame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
Change From Baseline in Cepstral Peak Prominence (dB)
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
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.
Time frame: 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
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
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.
Time frame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
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
Time frame: Baseline to post treatment
| Milestone | Voice Disorder Requiring Voice Therapy |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
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.
| score on a scale | Voice Disorder Requiring Voice Therapy |
|---|---|
| Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy | 7 (-3 to 17) |
CPP is an objective evaluation of voice recordings through specialized vocal analysis software.
| dB | Voice Disorder Requiring Voice Therapy |
|---|---|
| Change From Baseline in Cepstral Peak Prominence (dB) | -1.53 (-9.60 to 1.17) |
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.
| units on a scale | Voice Disorder Requiring Voice Therapy |
|---|---|
| Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity) | 15.39 (-6.92 to 81.95) |
mean airflow will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
| milliliters | Voice Disorder Requiring Voice Therapy |
|---|---|
| Change From Baseline in Mean Airflow in Milliliters (ml) During Reading of Standardized Paragraph | -52 (-138 to 105) |
mean vocal intensity will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
| decibels | Voice Disorder Requiring Voice Therapy |
|---|---|
| Change From Baseline in Mean Vocal Intensity (dB) | -1.7 (-19.11 to 6.44) |
Numeric value of the number of breaths needed to complete the reading of a paragraph. Values are positive integers
No measurements were reported for this outcome.
Collected over approximately 6 weeks for each participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Voice Disorder Requiring Voice Therapy | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Voice Disorder Requiring Voice Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Age, Continuous(years) | Voice Disorder Requiring Voice Therapy |
|---|---|
| Median | 38 (19 to 56) |
| Sex: Female, Male(Participants) | Voice Disorder Requiring Voice Therapy |
|---|---|
| Female | 8 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | Voice Disorder Requiring Voice Therapy |
|---|
| Region of Enrollment(participants) | Voice Disorder Requiring Voice Therapy |
|---|---|
| United States | 11 |
| Voice Handicap Index - 10(units on a scale) | Voice Disorder Requiring Voice Therapy |
|---|---|
| Mean | 17 (12 to 34) |
| Cepstral Peak Prominance-CPP(decibels) | Voice Disorder Requiring Voice Therapy |
|---|---|
| Mean | 10.43 (5.7 to 14.83) |
| Cepstral Spectral Index of Dysphonia (CSID)(units on a scale) | Voice Disorder Requiring Voice Therapy |
|---|---|
| Mean | -3.46 (-13.51 to 66.15) |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Any data shared would be completely de-identified. Currently there is no plan to share information at this time.
Supporting information: Study protocol, Sap, Icf
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