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NCT05492266 · Noel Jabbour

Expiratory Muscle Strength Training for Hypernasal Speech in Children

What this study is about

When the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency. The purpose of this research study is to test if soft palate exercises using a hand help breathing device will help improve the ability of the soft palate to close the area between the throat and nose and help improve speech.

View original scientific description

When the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency. The purpose of this research study is to test if soft palate exercises using a hand help breathing device will help improve the ability of the soft palate to close the area between the throat and nose and help improve speech.

Interventions

DEVICE

Expiratory Muscle Strength Training

At visit 1, participants will be block randomized based on PWSS score (5-6 or 7+) to Expiratory Muscle Strength Training (EMST) for 6 to 8 weeks or no exercises. Participants in the EMST-150 group will perform 5 sets of 5 resistive expirations once a day with a 10-15 second rest between each repetition and a 1-2 minute rest between each set of 5 repetitions.

DEVICE

Maintenance Training

At visit 2, participants with improved (decreased) CAPS-A hypernasality rating of 1 or more points, for whom the family and/or surgeon is not currently considering surgical intervention for VPI, will be further randomized to continue "maintenance" EMST exercises or no exercises for 6 months. Participants in the "maintenance" group will complete 3-5 sessions exercise sessions each week (rather than daily training), with 2 sets of 5 resistive expirations (rather than 5 sets)

Primary outcome measures

Change in nasalance scores after 6-8 weeks of exercises compared with baseline

Time frame: Baseline and 6-8 weeks

Percent change in nasalance measured during nasometry

Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline

Time frame: Baseline and 6-8 weeks

Perceptual symptoms of velopharyngeal incompetence measured using the CAPS-A-AM hypernasality score, on a scale of 0-4. 0 indicates nasality that is normal for the region, 1 (borderline/minimal) suggests a minimal or inconsistent increase in nasal resonance, 2 (mild) implies hypernasality that is evident on vowels with a high tongue posture, 3 (moderate) indicates hypernasality that is perceived across all vowels, and 4 (severe) signifies that hypernasality is evident in voiced consonants and all vowels.

Change in oral pressure following 6-8 weeks of exercises compared with baseline

Time frame: Baseline and 6-8 weeks

Percent change in oral pressure achieved when blowing through the EMST-150

Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline

Time frame: Baseline and 6-8 weeks

Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150

Change in oral pressure decay following 6-8 weeks of exercises compared with baseline

Time frame: Baseline and 6-8 weeks

Ratio of the magnitude of oral pressure decay when blowing through the EMST-150

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Pittsburgh weighted speech scores of 5 or greater
  • Ages 5-17 years

Exclusion criteria

  • CAPS-A-AM hypernasality score \<2
  • Previous speech surgery (e.g. palatoplasty or pharyngeal flap)
  • Speech surgery scheduled within the next 56 days
  • Unable or unwilling to perform the tests and exercises outlined in the study

Where

  • Pittsburgh, Pennsylvania

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Related conditions & keywords

Velopharyngeal InsufficiencyVelopharyngeal Incompetence Due to Cleft PalateInadequate Velopharyngeal ClosurePalatopharyngeal IncompetenceHypernasalityCleft PalateSpeech Intelligibility

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 22, 2025 · Source of record for eligibility and locations

📊
1 of 30 participants interested
3% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Pittsburgh

Pennsylvania

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Velopharyngeal Insufficiency Treatment in Pittsburgh?

Join others in Pennsylvania exploring innovative treatment options through clinical research

Velopharyngeal Insufficiency Treatment Options in Pittsburgh, Pennsylvania

If you're searching for Velopharyngeal Insufficiency treatment in Pittsburgh, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Pittsburgh and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Velopharyngeal Insufficiency. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Pennsylvania
Now Enrolling
Up to 30 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Velopharyngeal Insufficiency?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Velopharyngeal Insufficiency

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Velopharyngeal Insufficiency Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05492266. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.