The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Dysphonia Clinical Trial

Official title:

The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03692494
• Other study ID #: 20171103
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Adam T Lloyd, SLP-D, MM, MA, CCC-SLP
• Phone: 305-243-4315
• Email: adam.lloyd[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysphonia
• Paralysis
• Unilateral Vocal Cord Paralysis
• Vocal Cord Paralysis

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Dynamic pitch range	Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.	16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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