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NCT Number: NCT05492266

Expiratory Muscle Strength Training for Hypernasal Speech in Children

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.

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Key information

Conditions

Velopharyngeal Insufficiency Behavior Cleft Palate Communication Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Hypernasality Inadequate Velopharyngeal Closure Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Otorhinolaryngologic Diseases Palatopharyngeal Incompetence Pharyngeal Diseases Speech Speech Intelligibility Stomatognathic Diseases Stomatognathic System Abnormalities Velopharyngeal Incompetence Due to Cleft Palate Verbal Behavior

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location status: Recruiting

Location contact

Amber D Shaffer, PhD

CONTACT

[email protected]

412-692-6874

Cuneyt Alper, MD

SUB_INVESTIGATOR

Fendi Obuekwe

SUB_INVESTIGATOR

Jesse Goldstein, MD

SUB_INVESTIGATOR

Marina V Rushchak, BA

CONTACT

[email protected]

412-692-9879

Matthew Ford, MS

SUB_INVESTIGATOR

Nancy Gauvin, PhD

SUB_INVESTIGATOR

Noel Jabbour, MD

PRINCIPAL_INVESTIGATOR

About this study

The objective of this study is to examine the feasibility and efficacy of expiratory muscle strength training to improve velopharyngeal closure in patients with velopharyngeal dysfunction and nasal air emissions. A single-arm trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. Patients will perform Expiratory Muscle Strength Training for 6 to 8 weeks. Patients with reductions in nasal resonance during this time will be further randomized to EMST maintenance training for 6 months or no exercises.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Score of 2 or greater on the nasality/resonance domain of the Pittsburgh Weighted Speech Scale
  • Ages 5-17 years

Exclusion criteria

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

Treatment and study plan

Expiratory muscle strength training

Device

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.

Other names: EMST-150

Maintenance Training

Device

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 outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline

    Time frame: Baseline and 6-8 weeks

    Percent change in Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) scores. Scores range from 0 - 100, with 100 representing the highest QOL

  2. Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline.

    Time frame: Baseline and 6-8 weeks

    Percentage of participants with a change in tympanogram type from type B (flat) to type A (normal middle ear function).

  3. Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline.

    Time frame: Baseline and 6-8 weeks

    Percentage of participants with a change in tympanogram type from type C (negative pressure) to type A (normal middle ear function).

  4. Resolution of effusion following 6-8 weeks of exercises compared with baseline.

    Time frame: Baseline and 6-8 weeks

    Percentage of participants with resolution of middle ear effusion based on otoscopy.

  5. Resolution of retraction following 6-8 weeks of exercises compared with baseline.

    Time frame: Baseline and 6-8 weeks

    Percentage of participants with resolution of tympanic membrane retraction based on otoscopy

Other outcomes

  1. Change in nasalance scores after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

    Time frame: 6-8 weeks and 8 months

    Percent change in nasalance measured during nasometry

  2. Change in perceptual speech symptoms of velopharyngeal dysfunction after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

    Time frame: 6-8 weeks and 8 months

    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.

  3. Change in oral pressure after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

    Time frame: 6-8 weeks and 8 months

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

  4. Change in velopharyngeal flutter after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

    Time frame: 6-8 weeks and 8 months

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

  5. Change in oral pressure decay after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

    Time frame: 6-8 weeks and 8 months

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

  6. Prevalence of surgical intervention

    Time frame: 1 year

    Percentage of patients undergoing surgical intervention for speech symptoms within the 1 year following enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Amber D Shaffer, PhD

CONTACT

[email protected]

412-692-6874

Sponsors and collaborators

Lead sponsor

Noel Jabbour

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2022
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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