The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Not Applicable

Not yet recruiting

• Conditions: Dysphonia; Unilateral Vocal Cord Paralysis
• Interventions: Other: Standard of care voice therapy; Other: Expiratory muscle strength training (EMST)

• Registration Number: NCT03692494
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-30
• Study First Posted: 2018-10-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26
• Study Start: 2024-09-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral vocal fold paralysis standard of care voice therapy	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.
Unilateral paralysis standard of care voice therapy plus EMST	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.
Parkinson's disease standard of care voice therapy plus EMST	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.
Unilateral paralysis standard of care voice therapy plus EMST	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.
Parkinson's disease standard of care voice therapy plus EMST	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.

Primary Outcome Measures

Name	Time	Method
Maximum expiratory pressure	16 weeks	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	16 weeks	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

Name	Time	Method
Dynamic pitch range	16 weeks	Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.
Voice Handicap Index	16 weeks	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.
Peak expiratory flow rate	16 weeks	Peak expiratory flow rate, measured in units of liters per minute, will be measured for purposes of measuring cough function.
Cepstral Peak Prominence (CPP)	16 weeks	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)	16 weeks	Cepstral spectral index of dysphonia, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Fundamental frequency	16 weeks	Fundamental frequency, measured in herz, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Maximum phonation time	16 weeks	The patient will be asked to inhale deeply and sustain the vowel /a/ at a comfortable loudness level for a many seconds as possible.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States