Voice and Resonance DisordersNCT03410797
Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
A study testing Inclusion of semi-occluded mask in voice therapy in people with Voice and Resonance Disorders and Vocal Fold Polyp, run by Jacqueline Gartner-Schmidt at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Voice and Resonance Disorders, Vocal Fold Polyp, Vocal Cord Cyst
- What is being tested?
- Inclusion of semi-occluded mask in voice therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Current smoker (greater than 5 cigarettes/week)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
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.
Read the 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.
- Conditions
- Voice and Resonance Disorders, Vocal Fold Polyp, Vocal Cord Cyst, Vocal Cord Polyp, Atrophy of Vocal Cord
- Being tested
- Inclusion of semi-occluded mask in voice therapy
- Keywords
- SOVT, semi occluded vocal tract, voice disorder, voice therapy, muscle tension dysphonia, MTD, vocal fold lesions, vocal fold atrophy
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclusion of semi-occluded mask in voice therapyDevice
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 group | Role | What they receive |
|---|---|---|
| Voice Disorder Requiring Voice Therapy | Other | Individuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment. Receives: Device: Inclusion of semi-occluded mask in voice therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and approximately 6-8 weeks later; after completion of voice therapy
Secondary outcomes (5)
Change From Baseline in Cepstral Peak Prominence (dB)
CPP is an objective evaluation of voice recordings through specialized vocal analysis software.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline to post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start19 Jun 2018
- Primary completion30 Sep 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Voice and Resonance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacqueline Gartner-Schmidt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacqueline Gartner-Schmidt, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410797
- Sponsor's protocol ID
- PRO17100675
- Status last verified
- Dec 2020
- First submitted
- 5 Jan 2018
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Any data shared would be completely de-identified. Currently there is no plan to share information at this time.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
- ClinicalTrials.gov ID
- NCT03410797
- Acronym / sponsor ID
- PRO17100675
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Jacqueline Gartner-SchmidtUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voice Disorder Requiring Voice Therapy | Other | Device: Inclusion of semi-occluded mask in voice therapyIndividuals with a voice disorder such as muscle tension dysphonia (MTD), vocal fold atrophy or vocal fold lesions recommended for voice therapy as treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Current smoker (greater than 5 cigarettes/week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inclusion of semi-occluded mask in voice therapyPatients will be given a facemask with a semi-occlusion (SOMask) for use during in person voice therapy and for use at home therapy practice. | Device | Voice Disorder Requiring Voice Therapy |
Primary outcome
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.
5 secondary outcomes
Change From Baseline in Cepstral Peak Prominence (dB)
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)
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
Time frame: Baseline and approximately 6-8 weeks later; after completion of voice therapy
Change From Baseline in Mean Vocal Intensity (dB)
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
Time frame: Baseline to post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Any data shared would be completely de-identified. Currently there is no plan to share information at this time.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inclusion of semi-occluded mask in voice therapy in people with Voice and Resonance Disorders and Vocal Fold Polyp, run by Jacqueline Gartner-Schmidt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.