An interventional study of Standard of care voice therapy and Expiratory muscle strength training (EMST) in Dysphonia and Unilateral Vocal Cord Paralysis, sponsored by University of Miami. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
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
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 · Other: Expiratory muscle strength training (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 · Other: Expiratory muscle strength training (EMST)
Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder
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.
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.
Time frame: 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.
Time frame: 16 weeks
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.
Time frame: 16 weeks
Dynamic pitch range
Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks
Plan to share: No
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This study is withdrawn, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University of Miami