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

NCT03410797 | Completed Results FDA Device

• 1 other identifier: PRO17100675
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and approximately 6-8 weeks later; after completion of voice therapy

Secondary Outcomes (5)

• Change From Baseline in Cepstral Peak Prominence (dB)

  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)

  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

  Baseline and approximately 6-8 weeks later; after completion of voice therapy

• Change From Baseline in Mean Vocal Intensity (dB)

  Baseline and approximately 6-8 weeks later; after completion of voice therapy

• Change in the Number of Breaths Taken During Reading of Standardized Paragraph

  Baseline to post treatment

Study Arms (1)

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.

Device: Inclusion of semi-occluded mask in voice therapy

Interventions

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.

Voice Disorder Requiring Voice Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current smoker (greater than 5 cigarettes/week)

Sponsors & Collaborators

• Jacqueline Gartner-Schmidt: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jacqueline Gartner-Schmidt
• Organization: University of Pittsburgh

jgs@pitt.edu

412-232-8970

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 25, 2018
• Study Start: June 19, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: additional researchers may receive de-identified information only if a data use agreement has been executed.

Locations

US (1)