The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03692494

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphonia Unilateral Vocal Cord Paralysis	Other: Standard of care voice therapy Other: Expiratory muscle strength training (EMST)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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.

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

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)

Outcome Measures

Primary Outcome Measures

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

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.
Dynamic pitch range [16 weeks]
Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adam Lloyd, Speech Pathologist, University of Miami

ClinicalTrials.gov Identifier:

NCT03692494

Other Study ID Numbers:

20171103

First Posted:

Oct 2, 2018

Last Update Posted:

May 31, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dysphonia

Vocal Cord Paralysis

Paralysis

Study Results

No Results Posted as of May 31, 2022