Expiratory Muscle Strength Training for Hypernasal Speech

Overseen By Amber D Shaffer, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Noel Jabbour

Disqualifiers: Previous speech surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether exercises with a breathing device can improve speech problems caused by insufficient movement of the soft palate, often related to cleft palate. The main focus is on expiratory muscle strength training, a type of exercise aimed at closing the gap between the throat and nose, potentially enhancing speech. Participants will be divided into groups to test different exercise routines, with some doing maintenance training and others not. This trial may suit children and teens aged 5 to 17 who have significant speech issues and haven't undergone certain types of prior speech surgery. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could significantly improve speech for young participants.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this expiratory muscle strength training is safe for improving hypernasal speech?

Research shows that Expiratory Muscle Strength Training (EMST) is generally easy for people to handle. Studies have found it safe for individuals with various conditions, such as spinal cord injuries and multiple sclerosis, as well as for healthy people. This suggests the training is likely safe for many different individuals.

No major reports of negative effects have emerged, indicating that serious side effects are rare or nonexistent. This increases confidence that using a device like the EMST-150, which aids in breathing exercises, is unlikely to cause harm. Overall, current evidence supports the safety of this treatment for improving speech issues related to the soft palate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Expiratory Muscle Strength Training (EMST) for hypernasal speech because it offers a unique approach compared to traditional speech therapy techniques. Most treatments for hypernasality focus on articulation and resonance exercises, but EMST targets the underlying muscle strength involved in speech production. By using a device called EMST-150, this method strengthens the expiratory muscles, potentially leading to improved speech clarity. Additionally, EMST offers a structured, measurable way to track improvements, which could enhance its appeal over more subjective traditional methods.

What evidence suggests that this trial's treatments could be effective for hypernasal speech?

Research has shown that training the muscles used for breathing out, known as expiratory muscle strength training (EMST), can improve certain aspects of speech. One study found that people using EMST devices gained better control over their breathing muscles, which enhanced their speech. Specifically, the study showed improvements in breath strength and the ability to hold the "S" sound without voice. Other research has also noted improvements in breathing while speaking and overall speech function. In this trial, participants will undergo different EMST regimens, with some receiving additional maintenance training. These early findings suggest that EMST might benefit people with nasal-sounding speech due to conditions like a cleft palate. ^{1 2 3 6 7}

Who Is on the Research Team?

Noel Jabbour, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for children aged 5-17 with a speech difference called velopharyngeal insufficiency, often due to cleft palate. They should have noticeable speech issues (score of 3 or higher on a specific scale) and must be able to do the exercises in the study. Kids who've had previous speech surgery or have one scheduled within two months can't join.

Inclusion Criteria

I am between 5 and 17 years old.

Pittsburgh weighted speech scores of 3 or greater

Exclusion Criteria

Unable or unwilling to perform the tests and exercises outlined in the study

I have had surgery to improve my speech.

I have a speech surgery planned within the next 56 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Expiratory Muscle Strength Training (EMST) for 6-8 weeks to improve velopharyngeal closure

6-8 weeks

Maintenance Training

Participants with improvement in hypernasality rating continue with maintenance training for 6 months

6 months

Follow-up

Participants are monitored for changes in nasalance scores and other speech-related outcomes

8 months

What Are the Treatments Tested in This Trial?

Interventions

• Expiratory Muscle Strength Training
• Maintenance Training

Trial Overview The study tests if using a handheld breathing device for soft palate exercises can improve the closing function between throat and nose, potentially enhancing speech quality in kids with velopharyngeal insufficiency.

How Is the Trial Designed?

Group I: Expiratory Muscle Strength Training + No Maintenance Training Experimental Treatment 1 Intervention

These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their CAPS-A hypernasality rating of 1 point or more and were randomized to complete 6 months of no maintenance training.

Group II: Expiratory Muscle Strength Training + Maintenance Training Experimental Treatment 2 Interventions

These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their CAPS-A hypernasality rating of 1 point or more and were randomized to complete 6 months of maintenance training.

Group III: Expiratory Muscle Strength Training Experimental Treatment 1 Intervention

These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They did not have improvement in their CAPS-A hypernasality rating of 1 point or more and ended active study participation after the initial 6-8 weeks of exercises.

Group IV: No Exercises Active Control 1 Intervention

These participants were initially randomized to 6-8 weeks of no exercises. They ended active study participation after the initial 6-8 weeks of no exercises. They were not eligible to be randomized to maintenance training or no maintenance training.

Who Is Running the Clinical Trial?

Noel Jabbour

Lead Sponsor

Trials

2

Recruited

40+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Expiratory muscle strength training significantly improved maximal expiratory pressure (MEP) and voiceless /S/ expiratory time in 29 hospital workers with voice disorders, indicating enhanced vocal performance after 5 weeks of training.

Participants in the training group reported better vocal symptoms and showed greater improvements in phonation compared to the control group, suggesting that targeted expiratory exercises can effectively benefit those with voice-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Expiratory Muscle Strength Training on Voice and Associated Factors in Medical Professionals With Voice Disorders. Tsai, YC., Huang, S., Che, WC., et al.[2017]

A high-intensity, low-repetition expiratory training method significantly increased expiratory muscle strength in 40 healthy high school band players after just 2 weeks of training, demonstrating its efficacy.

The training was effective across different instruments, suggesting that this method can be broadly applied to enhance expiratory pressure support for various musical needs and potentially for other respiratory support applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory muscle training increases pressure support in high school band students. Sapienza, CM., Davenport, PW., Martin, AD.[2022]

A new therapy using a CPAP device has been introduced to treat hypernasality by strengthening the velopharyngeal closure muscles through resistance training.

Preliminary results from six case studies indicate that this CPAP therapy may effectively reduce hypernasality in individuals with mild to moderate severity over an 8-week treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New therapy for treating hypernasal speech using continuous positive airway pressure (CPAP). Kuehn, DP.[2019]

Inspiratory muscle strength training shows promise for improving voice disorders, particularly in conditions like abductor vocal fold paralysis and paradoxical vocal cord dysfunction, based on limited studies and case reports.

Current research indicates mixed results for respiratory muscle training in populations with voice disorders, such as no significant improvements in speech production for patients with multiple sclerosis, while ongoing trials for Parkinson's disease have yet to report outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle strength training applications. Sapienza, CM.[2022]

A study involving 43 subjects with cleft palate showed that 8 weeks of velopharyngeal resistance training using CPAP significantly reduced speech hypernasality, with an average reduction of 0.20 units on a scale of 1.0 to 7.0.

The effectiveness of the treatment varied among patients, with some experiencing substantial improvements while others showed increased hypernasality, indicating that while CPAP can help some individuals, responses to the therapy can differ widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of continuous positive airway pressure for treatment of hypernasality. Kuehn, DP., Imrey, PB., Tomes, L., et al.[2018]

Expiratory muscle strength training (EMST) for 8 weeks significantly improved oral functions in older adults, as evidenced by a shorter cumulative swallowing time and increased maximum phonation time compared to a control group.

The intervention also enhanced respiratory functions, with a notable increase in maximum expiratory pressure in the EMST group, indicating that this training can positively impact both swallowing and breathing capabilities in community-dwelling elderly individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of expiratory muscle strength training on the oral and respiratory functions of community-dwelling older people: An analysis using the swallowing, oral, phonatory, and respiratory muscle function indices. Ito, N., Watanabe, S.[2019]

In a study involving 15 patients with multiple system atrophy (MSA), an 8-week expiratory muscle strength training (EMST) program significantly improved maximal expiratory pressure (MEP), indicating enhanced expiratory muscle strength (P = 0.006).

However, the training did not lead to significant improvements in voluntary peak cough flow (vPCF) (P = 0.845), suggesting that while EMST can strengthen muscles, it may not directly enhance cough effectiveness in MSA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expiratory Muscle Strength Training in Multiple System Atrophy: A Pilot Study. Srp, M., Bartosova, T., Klempir, J., et al.[2023]

Participants in an expiratory muscle strength training (EMST) program showed significant strength gains, with a 41% increase after 4 weeks and a 51% increase after 8 weeks, indicating that EMST is effective for improving expiratory muscle strength.

After an 8-week detraining period, participants maintained significantly higher expiratory muscle strength compared to baseline, suggesting that the benefits of EMST persist even after training stops, regardless of the training duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of strength training and detraining effects in expiratory muscles. Baker, S., Davenport, P., Sapienza, C.[2022]

A 4-week expiratory muscle strength training program, using a pressure threshold device, showed up to a 50% improvement in respiratory muscle strength among healthy individuals and those with conditions like multiple sclerosis and spinal cord injury.

The training protocol, which involves 15-20 minutes of daily exercises five times a week, is designed to enhance expiratory muscle strength and may also positively impact functional outcomes and brain plasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle strength training: functional outcomes versus plasticity. Sapienza, CM., Wheeler, K.[2022]

In a study involving 12 healthy participants, both 3 days and 5 days per week of expiratory muscle strength training (EMST) led to similar improvements in maximum expiratory pressure (MEP), indicating that less frequent training can be just as effective.

Overall, participants showed a significant 33% increase in MEP over the 4-week training period, suggesting that training frequency may be an important factor to consider in developing effective treatment protocols for patients with expiratory muscle weakness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of training frequency on maximum expiratory pressure. Anand, S., El-Bashiti, N., Sapienza, C.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05492266

Expiratory Muscle Strength Training for Hypernasal ... These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their CAPS-A hypernasality rating of 1 ...

2. withpower.com withpower.com/trial/phase-inadequate-velopharyngeal-closure-7-2022-4b774

Expiratory Muscle Strength Training for Hypernasal Speech Expiratory muscle strength training significantly improved maximal expiratory pressure (MEP) and voiceless /S/ expiratory time in 29 hospital workers with voice ...

3. ctv.veeva.com ctv.veeva.com/study/expiratory-muscle-strength-training-for-hypernasal-speech-in-children

Expiratory Muscle Strength Training for Hypernasal Speech in ... These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their CAPS-A ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5945060/

The Impact of Expiratory Muscle Strength Training on ... The purpose of this study was to examine the impact of expiratory muscle strength training on speech breathing and functional speech outcomes in individuals ...

5. researchgate.net researchgate.net/publication/374427484_Effect_of_expiratory_muscle_strength_training_on_voice_and_speech_An_exploratory_study_in_persons_with_Parkinson's_disease_or_multiple_sclerosis

Effect of expiratory muscle strength training on voice and ... Conclusion: The results of this study support previous evidence that EMST has positive effects on expiratory pressure in persons with PD or MS, ...

6. tc.columbia.edu tc.columbia.edu/media/centers-amp-labs/lab-for-upper-airway-dysfunction/uad-research-papers/ASHA-2023-RMST-Slides.pdf

Respiratory Muscle Strength Training (RMST) Patient expires forcefully into a one- way spring loaded & calibrated trainer. Patient inspires rapidly into a one-way spring loaded & calibrated trainer. EMST.

7. researchgate.net researchgate.net/publication/230875316_Expiratory_Muscle_Strength_Training_in_the_Treatment_of_Mixed_Dysarthria_in_a_Patient_with_Lance-Adams_Syndrome

Expiratory Muscle Strength Training in the Treatment of ... It has also been shown that expiratory muscle strength training (EMST) can be practical for treating verbal symptoms associated with LAS [80] .