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Expiratory Muscle Strength Training + Voice Therapy for Vocal Cord Paralysis
N/A
Waitlist Available
Led By Adam T Lloyd, SLP-D, MM, MA
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Non English or Spanish speakers
Individuals with uncontrolled blood pressure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if adding breathing muscle exercises to regular voice therapy helps people with voice problems due to vocal cords not closing properly. The goal is to see if it improves their breath control, speaking ability, and overall voice quality.
Who is the study for?
This trial is for adults over 18 with glottal insufficiency, who've seen a speech pathologist and otolaryngologist. They must score at least 24 on the MMSE, showing they can follow therapy instructions. It's not for those unable to consent, non-English/Spanish speakers, pregnant women, prisoners, or people with certain medical conditions like uncontrolled blood pressure or chronic respiratory diseases.
What is being tested?
The study tests if adding expiratory muscle strength training (EMST) to standard voice therapy improves breathing strength and voice quality in individuals with vocal cord issues. The goal is to see better maximal expiratory pressure and voice measures such as loudness and duration of sound.
What are the potential side effects?
Potential side effects from EMST may include discomfort while using the device or fatigue due to the exercises. Standard voice therapy generally has minimal risks but could also cause temporary vocal strain or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My mental ability to participate in therapy is confirmed by a test score.
Select...
I have completed a voice check with speech and throat specialists.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English or Spanish.
Select...
My blood pressure is not under control.
Select...
I do not have severe, unmanaged lung conditions like COPD.
Select...
I am unable to give consent for medical procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Amplitude
Maximum expiratory pressure
Secondary study objectives
Cepstral Peak Prominence (CPP)
Cepstral spectral index of dysphonia (CSID)
Dynamic pitch range
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Unilateral vocal fold paralysis standard of care voice therapyExperimental Treatment1 Intervention
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.
Group II: Unilateral paralysis standard of care voice therapy plus EMSTExperimental Treatment2 Interventions
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.
Group III: Parkinson's disease standard of care voice therapy plus EMSTExperimental Treatment2 Interventions
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Expiratory Muscle Strength Training (EMST) strengthens the expiratory muscles to enhance respiratory support for phonation, which is crucial for improving voice quality in hoarseness patients. This approach directly addresses muscle weakness that can impair vocal function.
Other treatments, such as visual EMG biofeedback and manual circumlaryngeal therapy, reduce laryngeal muscle tension and improve muscle coordination, further enhancing voice quality. These non-surgical therapies are vital for managing hoarseness, offering patients improved communication abilities and quality of life.
EMG biofeedback treatment of pediatric hyperfunctional dysphonia.The Immediate Impact of Targeted Exercises on Voice Characteristics in Female Speakers With Phonotraumatic Vocal Fold Lesions.Effectiveness of voice therapy in patients with vocal fold nodules: a systematic search and narrative review.
EMG biofeedback treatment of pediatric hyperfunctional dysphonia.The Immediate Impact of Targeted Exercises on Voice Characteristics in Female Speakers With Phonotraumatic Vocal Fold Lesions.Effectiveness of voice therapy in patients with vocal fold nodules: a systematic search and narrative review.
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Who is running the clinical trial?
University of MiamiLead Sponsor
947 Previous Clinical Trials
427,585 Total Patients Enrolled
Adam T Lloyd, SLP-D, MM, MAPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My mental ability to participate in therapy is confirmed by a test score.You have a problem with the opening of your vocal cords.My blood pressure is not under control.I have a stable stomach condition, except for well-managed acid reflux.I do not speak English or Spanish.You have trouble following instructions because of a severe mental health condition like depression or psychosis.I am 18 years old or older.I do not have severe, unmanaged lung conditions like COPD.I have completed a voice check with speech and throat specialists.I am unable to give consent for medical procedures.You have had a hernia in your abdomen before.You have a neurological or muscle disorder other than Parkinson's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Unilateral paralysis standard of care voice therapy plus EMST
- Group 2: Unilateral vocal fold paralysis standard of care voice therapy
- Group 3: Parkinson's disease standard of care voice therapy plus EMST
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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