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The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03692494
Enrollment
0
Registered
2018-10-02
Start date
2025-04-01
Completion date
2026-12-01
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphonia, Unilateral Vocal Cord Paralysis

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.

Interventions

OTHERStandard 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

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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum expiratory pressure16 weeksMaximum expiratory pressure, in cm of H2O, will be measured to evaluate how much pressure a participant can blow into a respiratory pressure meter.
Amplitude16 weeksAmplitude 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

MeasureTime frameDescription
Cepstral Peak Prominence (CPP)16 weeksCepstral 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 weeksCepstral spectral index of dysphonia, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Fundamental frequency16 weeksFundamental frequency, measured in herz, will be obtained using the Analysis of Dysphonia in Speech and Voice on Kay Pentax Computerized Speech Lab.
Maximum phonation time16 weeksThe 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 rate16 weeksPeak expiratory flow rate, measured in units of liters per minute, will be measured for purposes of measuring cough function.
Voice Handicap Index16 weeksThis 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.
Dynamic pitch range16 weeksDynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026