What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for hoarseness, particularly non-invasive voice therapies like Expiratory Muscle Strength Training (EMST), generally have minimal side effects. These therapies aim to strengthen the respiratory muscles and improve vocal function. Potential side effects may include temporary muscle fatigue, mild discomfort, or soreness in the throat or respiratory muscles. In rare cases, overexertion during exercises could lead to vocal strain or temporary worsening of hoarseness. It is important to follow a structured program under professional guidance to minimize these risks.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for hoarseness that directly involve strengthening expiratory muscles for improved respiratory support for phonation. However, treatments for conditions that affect voice quality, such as glottal insufficiency, often include voice therapy and sometimes involve the use of injectable soft tissue fillers like hyaluronic acid or collagen to improve vocal fold function. These treatments aim to enhance vocal fold closure and improve voice quality, indirectly supporting phonation. For pediatric hyperfunctional dysphonia, EMG biofeedback has shown effectiveness in reducing muscle tension and improving voice quality, though it is not specifically FDA-approved for hoarseness.

What other types of research exist?

A promising novel alternative to Expiratory Muscle Strength Training for hoarseness patients is EMG biofeedback training. This method involves visual feedback to help patients reduce laryngeal muscle tension, which has been shown to improve voice quality and eliminate vocal nodules without surgical intervention. Another potential option is the use of oscillatory devices, which have been shown to improve mucus movement and may help in conditions with excessive mucus production affecting voice quality.

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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 below

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My mental ability to participate in therapy is confirmed by a test score.

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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:

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I do not speak English or Spanish.

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My blood pressure is not under control.

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I do not have severe, unmanaged lung conditions like COPD.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

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 more

Awards & 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

0 / 6Eligibility criteria met

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.