N/A
N=11
Efficacy of a Semi-occluded Mask in the Treatment of Patients With Voice Disorders
Voice and Resonance Disorders · Vocal Fold Polyp · Vocal Cord Cyst · Vocal Cord Polyp · Atrophy of Vocal Cord
Bottom Line
View on ClinicalTrials.gov: NCT03410797 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy — 7 score on a scale — p=.0076
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inclusion of semi-occluded mask in voice therapy (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jacqueline Gartner-Schmidt
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in VHI-10 Score After 4 Sessions of Voice Therapy |
7 | .0076 sig |
| SECONDARY Change From Baseline in Cepstral Peak Prominence (dB) |
-1.53 | .0329 sig |
| SECONDARY Change From Baseline in Cepstral Spectral Index of Dysphonia (CSID--a Multivariate Estimate of Dysphonia Severity) |
15.39 | .0164 sig |
| SECONDARY Change From Baseline in Mean Airflow in Milliliters (ml) During Reading of Standardized Paragraph |
-52 | 0.1141 |
| SECONDARY Change From Baseline in Mean Vocal Intensity (dB) |
-1.7 | .3329 |
| SECONDARY Change in the Number of Breaths Taken During Reading of Standardized Paragraph |
— | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03410797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.