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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03410797

Enrollment

Registered

2018-01-25

Start date

2018-06-19

Completion date

2019-12-30

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophy of Vocal Cord, Vocal Cord Cyst, Vocal Cord Polyp, Vocal Fold Polyp, Voice and Resonance Disorders

Keywords

SOVT, semi occluded vocal tract, voice disorder, voice therapy, muscle tension dysphonia, MTD, vocal fold lesions, vocal fold atrophy

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.

Interventions

DEVICEInclusion 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy	Baseline and approximately 6-8 weeks later; after completion 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

Measure	Time frame	Description
Change From Baseline in Cepstral Peak Prominence (dB)	Baseline and approximately 6-8 weeks later; after completion of voice therapy	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)	Baseline and approximately 6-8 weeks later; after completion of voice therapy	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	Baseline and approximately 6-8 weeks later; after completion of voice therapy	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)	Baseline and approximately 6-8 weeks later; after completion of voice therapy	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	Baseline to post treatment	Numeric value of the number of breaths needed to complete the reading of a paragraph. Values are positive integers

Countries

United States

Participant flow

Participants by arm

Arm	Count
Voice Disorder Requiring Voice Therapy Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment. 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.	11
Total	11

Baseline characteristics

Characteristic	Voice Disorder Requiring Voice Therapy	—
Age, Categorical <=18 years	0 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	11 Participants	—
Age, Continuous	38 years	—
Cepstral Peak Prominance-CPP	10.43 decibels	—
Cepstral Spectral Index of Dysphonia (CSID)	-3.46 units on a scale	—
Mean Airflow	138 mL/s	—
Mean vocal intensity	66.75 dB SPL	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	11 participants	—
Sex: Female, Male Female	8 Participants	—
Sex: Female, Male Male	3 Participants	—
Voice Diagnoses Diagnosis of Lesions	3 participants	—
Voice Diagnoses Diagnosis of Muscle Tension Dysphonia	8 participants	—
Voice Handicap Index - 10	17 units on a scale	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 11
other Total, other adverse events	0 / 11
serious Total, serious adverse events	0 / 11

Outcome results

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.