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The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Primary Purpose

Dysphonia, Unilateral Vocal Cord Paralysis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of care voice therapy
Expiratory muscle strength training (EMST)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals with glottic insufficiency.
  • Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy
  • Completed voice combination evaluation with speech pathologists and otolaryngologist.
  • Individuals 18 years of age or older

Exclusion Criteria:

  • Adults unable to consent
  • Non English or Spanish speakers
  • Pregnant women
  • Prisoners
  • Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis.
  • Individuals with uncontrolled blood pressure.
  • Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD.
  • Individuals with a history of abdominal hernia.
  • Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis).
  • Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Unilateral vocal fold paralysis standard of care voice therapy

Unilateral paralysis standard of care voice therapy plus EMST

Parkinson's disease standard of care voice therapy plus EMST

Arm Description

The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques.

The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.

The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.

Outcomes

Primary Outcome Measures

Maximum expiratory pressure
Maximum expiratory pressure, in cm of H2O, will be measured to evaluate how much pressure a participant can blow into a respiratory pressure meter.
Amplitude
Amplitude of voice, in decibels, will be measured using Voice Range Profile on Kay Pentax CSL and will be compared to gender matched normative values for normal and loud volumes.

Secondary Outcome Measures

Fundamental frequency
Fundamental frequency, measured in herz, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Dynamic pitch range
Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.
Cepstral Peak Prominence (CPP)
Cepstral Peak Prominence will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Cepstral spectral index of dysphonia (CSID)
Cepstral spectral index of dysphonia, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Voice Handicap Index
This is quality of life assessment tool quantifying perception of the impact of their vocal disorder on various aspects of lifestyle. It is 30-questions in length and is divided into 3 subscales including emotional, physical, and functional, divided into 10 questions each. Each question scored from 0-4. Total score range from 0-120. Higher score indicates increased handicap.
Maximum phonation time
The patient will be asked to inhale deeply and sustain the vowel /a/ at a comfortable loudness level for a many seconds as possible.
Peak expiratory flow rate
Peak expiratory flow rate, measured in units of liters per minute, will be measured for purposes of measuring cough function.

Full Information

First Posted
September 26, 2018
Last Updated
May 31, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03692494
Brief Title
The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy
Official Title
The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate if adding expiratory muscle strength training to traditional voice therapy for individuals with dysphonia due to glottal insufficiency improves maximal expiratory pressure, acoustic and aerodynamic measures (i.e. amplitude, maximum phonation time, peak expiratory flow), and voice related quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia, Unilateral Vocal Cord Paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unilateral vocal fold paralysis standard of care voice therapy
Arm Type
Experimental
Arm Description
The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques.
Arm Title
Unilateral paralysis standard of care voice therapy plus EMST
Arm Type
Experimental
Arm Description
The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.
Arm Title
Parkinson's disease standard of care voice therapy plus EMST
Arm Type
Experimental
Arm Description
The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.
Intervention Type
Other
Intervention Name(s)
Standard of care voice therapy
Intervention Description
Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder
Intervention Type
Other
Intervention Name(s)
Expiratory muscle strength training (EMST)
Intervention Description
EMST150 used at 75% of their maximum expiratory pressure. Participants will be directed to perform 5 sets of 5 breaths, 5 days per week, for 5 weeks, at the pressure threshold established in therapy. Maximum expiratory pressure will then be determined at the beginning of each therapy session and recalibration of the device will be performed if indicated.
Primary Outcome Measure Information:
Title
Maximum expiratory pressure
Description
Maximum expiratory pressure, in cm of H2O, will be measured to evaluate how much pressure a participant can blow into a respiratory pressure meter.
Time Frame
16 weeks
Title
Amplitude
Description
Amplitude of voice, in decibels, will be measured using Voice Range Profile on Kay Pentax CSL and will be compared to gender matched normative values for normal and loud volumes.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Fundamental frequency
Description
Fundamental frequency, measured in herz, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Time Frame
16 weeks
Title
Dynamic pitch range
Description
Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.
Time Frame
16 weeks
Title
Cepstral Peak Prominence (CPP)
Description
Cepstral Peak Prominence will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Time Frame
16 weeks
Title
Cepstral spectral index of dysphonia (CSID)
Description
Cepstral spectral index of dysphonia, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Time Frame
16 weeks
Title
Voice Handicap Index
Description
This is quality of life assessment tool quantifying perception of the impact of their vocal disorder on various aspects of lifestyle. It is 30-questions in length and is divided into 3 subscales including emotional, physical, and functional, divided into 10 questions each. Each question scored from 0-4. Total score range from 0-120. Higher score indicates increased handicap.
Time Frame
16 weeks
Title
Maximum phonation time
Description
The patient will be asked to inhale deeply and sustain the vowel /a/ at a comfortable loudness level for a many seconds as possible.
Time Frame
16 weeks
Title
Peak expiratory flow rate
Description
Peak expiratory flow rate, measured in units of liters per minute, will be measured for purposes of measuring cough function.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with glottic insufficiency. Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy Completed voice combination evaluation with speech pathologists and otolaryngologist. Individuals 18 years of age or older Exclusion Criteria: Adults unable to consent Non English or Spanish speakers Pregnant women Prisoners Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis. Individuals with uncontrolled blood pressure. Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD. Individuals with a history of abdominal hernia. Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis). Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam T Lloyd, SLP-D, MM, MA, CCC-SLP
Phone
305-243-4315
Email
adam.lloyd@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Costanza Pelusso, FMG, CCRP
Phone
305-243-7102
Email
cpelusso@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam T Lloyd, SLP-D, MM, MA
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam T Lloyd, SLP-D, MM, MA
Phone
305-243-4315
Email
adam.lloyd@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Adam T Lloyd, SLP-D, MM, MA

12. IPD Sharing Statement

Plan to Share IPD
No

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