The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Unilateral Vocal Cord Paralysis; Dysphonia
• Intervention / Treatment: Other: Standard of care voice therapy; Other: Expiratory muscle strength training (EMST)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam T Lloyd, SLP-D, MM, MA, CCC-SLP; Phone Number: 305-243-4315; Email: adam.lloyd@med.miami.edu
• Study Contact Backup: Name: Costanza Pelusso, FMG, CCRP; Phone Number: 305-243-7102; Email: cpelusso@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
      • Contact: Adam T Lloyd, SLP-D, MM, MA; Phone Number: 305-243-4315; Email: adam.lloyd@med.miami.edu
      • Principal Investigator: Adam T Lloyd, SLP-D, MM, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unilateral vocal fold paralysis standard of care voice therapy; 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.	Other: Standard of care voice therapy; Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder
Experimental: Unilateral paralysis standard of care voice therapy plus EMST; 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.	Other: Standard of care voice therapy; Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder; Other: Expiratory muscle strength training (EMST); 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.
Experimental: Parkinson's disease standard of care voice therapy plus EMST; 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.	Other: Standard of care voice therapy; Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder; Other: Expiratory muscle strength training (EMST); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks
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.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks
Dynamic pitch range	Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.	16 weeks
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.	16 weeks
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.	16 weeks
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.	16 weeks
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.	16 weeks
Peak expiratory flow rate	Peak expiratory flow rate, measured in units of liters per minute, will be measured for purposes of measuring cough function.	16 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Adam T Lloyd, SLP-D, MM, MA, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 30, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Vagus Nerve Diseases; Voice Disorders; Paralysis; Vocal Cord Paralysis; Dysphonia
• Other Study ID Numbers: 20171103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No