Trial Outcomes & Findings for Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders (NCT NCT03410797)
NCT ID: NCT03410797
Last Updated: 2021-01-05
Results Overview
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.
COMPLETED
NA
11 participants
Baseline and approximately 6-8 weeks later; after completion of voice therapy
2021-01-05
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Voice Disorder Requiring Voice Therapy
n=11 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=11 Participants
|
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Age, Categorical
Between 18 and 65 years
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11 Participants
n=11 Participants
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Age, Categorical
>=65 years
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0 Participants
n=11 Participants
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Age, Continuous
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38 years
n=11 Participants
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|
Sex: Female, Male
Female
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8 Participants
n=11 Participants
|
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Sex: Female, Male
Male
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3 Participants
n=11 Participants
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Region of Enrollment
United States
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11 participants
n=11 Participants
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Voice Handicap Index - 10
|
17 units on a scale
n=11 Participants
|
|
Cepstral Peak Prominance-CPP
|
10.43 decibels
n=11 Participants
|
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Cepstral Spectral Index of Dysphonia (CSID)
|
-3.46 units on a scale
n=11 Participants
|
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Mean Airflow
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138 mL/s
n=11 Participants
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Mean vocal intensity
|
66.75 dB SPL
n=11 Participants
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Voice Diagnoses
Diagnosis of Lesions
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3 participants
n=11 Participants
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Voice Diagnoses
Diagnosis of Muscle Tension Dysphonia
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8 participants
n=11 Participants
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PRIMARY outcome
Timeframe: Baseline and approximately 6-8 weeks later; after completion of voice therapyVHI-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.
Outcome measures
| Measure |
Voice Disorder Requiring Voice Therapy
n=11 Participants
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.
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|---|---|
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Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy
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7 score on a scale
Interval -3.0 to 17.0
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SECONDARY outcome
Timeframe: Baseline and approximately 6-8 weeks later; after completion of voice therapyCPP is an objective evaluation of voice recordings through specialized vocal analysis software.
Outcome measures
| Measure |
Voice Disorder Requiring Voice Therapy
n=11 Participants
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.
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|---|---|
|
Change From Baseline in Cepstral Peak Prominence (dB)
|
-1.53 dB
Interval -9.6 to 1.17
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SECONDARY outcome
Timeframe: Baseline and approximately 6-8 weeks later; after completion of voice therapyCSID 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.
Outcome measures
| Measure |
Voice Disorder Requiring Voice Therapy
n=11 Participants
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.
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|---|---|
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Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity)
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15.39 units on a scale
Interval -6.92 to 81.95
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SECONDARY outcome
Timeframe: Baseline and approximately 6-8 weeks later; after completion of voice therapymean airflow will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
Outcome measures
| Measure |
Voice Disorder Requiring Voice Therapy
n=11 Participants
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.
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|---|---|
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Change From Baseline in Mean Airflow in Milliliters (ml) During Reading of Standardized Paragraph
|
-52 milliliters
Interval -138.0 to 105.0
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SECONDARY outcome
Timeframe: Baseline and approximately 6-8 weeks later; after completion of voice therapymean vocal intensity will be captured during the phonatory aerodynamic system (PAS) recording of airflow during the reading of the standardized paragraph.
Outcome measures
| Measure |
Voice Disorder Requiring Voice Therapy
n=11 Participants
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.
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|---|---|
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Change From Baseline in Mean Vocal Intensity (dB)
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-1.7 decibels
Interval -19.11 to 6.44
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SECONDARY outcome
Timeframe: Baseline to post treatmentPopulation: This information was not collected during this study on any of the participants. Therefore, there was no data to analyze.
Numeric value of the number of breaths needed to complete the reading of a paragraph. Values are positive integers
Outcome measures
Outcome data not reported
Adverse Events
Voice Disorder Requiring Voice Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place