DysphoniaNCT03692494
The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy
A study testing Expiratory muscle strength training (EMST) in people with Dysphonia and Unilateral Vocal Cord Paralysis, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphonia, Unilateral Vocal Cord Paralysis
- What is being tested?
- Expiratory muscle strength training (EMST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dysphonia, Unilateral Vocal Cord Paralysis
- Being tested
- Standard of care voice therapy, Expiratory muscle strength training (EMST)
- Medical subject headings
- Dysphonia, Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care voice therapyOther
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral vocal fold paralysis standard of care voice therapy | Experimental | 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. Receives: Other: Standard of care voice therapy |
| Unilateral paralysis standard of care voice therapy plus EMST | Experimental | 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. Receives: Other: Standard of care voice therapy; Other: Expiratory muscle strength training (EMST) |
| Parkinson's disease standard of care voice therapy plus EMST | Experimental | 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. Receives: Other: Standard of care voice therapy; Other: Expiratory muscle strength training (EMST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 weeks
Secondary outcomes (7)
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.
Measured: 16 weeks
Dynamic pitch range
Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Apr 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: PI did decided reorganize the methodology for this study and will resubmit in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Lloyd, University of Miami
- Investigators
- Adam T Lloyd, SLP-D, MM, MA, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692494
- Sponsor's protocol ID
- 20171103
- Status last verified
- Feb 2025
- First submitted
- 26 Sep 2018
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy
- ClinicalTrials.gov ID
- NCT03692494
- Acronym / sponsor ID
- 20171103
- Conditions
- Dysphonia, Unilateral Vocal Cord Paralysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI did decided reorganize the methodology for this study and will resubmit in the future.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral vocal fold paralysis standard of care voice therapy | Experimental | Other: Standard of care voice therapyThe 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 | Experimental | 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. |
| Parkinson's disease standard of care voice therapy plus EMST | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care voice therapyExercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder | Other | Parkinson's disease standard of care voice therapy plus EMST, Unilateral paralysis standard of care voice therapy plus EMST, Unilateral vocal fold paralysis standard of care voice therapy |
| 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. | Other | Parkinson's disease standard of care voice therapy plus EMST, Unilateral paralysis standard of care voice therapy plus EMST |
Primary outcome
Maximum expiratory pressure
Time frame: 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
Time frame: 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.
7 secondary outcomes
Fundamental frequency
Time frame: 16 weeks
Dynamic pitch range
Time frame: 16 weeks
Cepstral Peak Prominence (CPP)
Time frame: 16 weeks
Cepstral spectral index of dysphonia (CSID)
Time frame: 16 weeks
Voice Handicap Index
Time frame: 16 weeks
Maximum phonation time
Time frame: 16 weeks
Peak expiratory flow rate
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam T Lloyd, SLP-D, MM, MA principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory muscle strength training (EMST) in people with Dysphonia and Unilateral Vocal Cord Paralysis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum expiratory pressure (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.