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Completed

NCT Number: NCT03410797

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

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.

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Key information

Conditions

Voice and Resonance Disorders Atrophy of Vocal Cord Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Vocal Cord Cyst Vocal Cord Polyp Vocal Fold Polyp Voice Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Inclusion of semi-occluded mask in voice therapy

Device

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.

Primary outcomes

  1. Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy

    Time frame: 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 outcomes

  1. Change From Baseline in Cepstral Peak Prominence (dB)

    Time frame: 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.

  2. Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity)

    Time frame: 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.

  3. Change From Baseline in Mean Airflow in Milliliters (ml) During Reading of Standardized Paragraph

    Time frame: 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.

  4. Change From Baseline in Mean Vocal Intensity (dB)

    Time frame: 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.

  5. Change in the Number of Breaths Taken During Reading of Standardized Paragraph

    Time frame: Baseline to post treatment

    Numeric value of the number of breaths needed to complete the reading of a paragraph.

    Values are positive integers

Sponsors and collaborators

Lead sponsor

Jacqueline Gartner-Schmidt

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2018
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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