Expiratory Muscle Strength Training for Hypernasal Speech in Children

NCT05492266 | Recruiting FDA Device

• 2 other identifiers: STUDY211200325R21DC017553-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Velopharyngeal Insufficiency; Velopharyngeal Incompetence Due to Cleft Palate; Inadequate Velopharyngeal Closure; Palatopharyngeal Incompetence; Hypernasality

Keywords

Cleft Palate; Speech Intelligibility

Outcome Measures

Primary Outcomes (5)

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

  Percent change in nasalance measured during nasometry

  Baseline and 6-8 weeks

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

  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.

  Baseline and 6-8 weeks

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

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

  Baseline and 6-8 weeks

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

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

  Baseline and 6-8 weeks

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

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

  Baseline and 6-8 weeks

Secondary Outcomes (5)

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

  Baseline and 6-8 weeks

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

  Baseline and 6-8 weeks

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

  Baseline and 6-8 weeks

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

  Baseline and 6-8 weeks

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

  Baseline and 6-8 weeks

Other Outcomes (6)

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

  6-8 weeks and 8 months

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

  6-8 weeks and 8 months

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

  6-8 weeks and 8 months

Study Arms (4)

Expiratory Muscle Strength Training + No Maintenance Training

EXPERIMENTAL

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.

Device: Expiratory Muscle Strength Training

No Exercises

NO 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.

Expiratory Muscle Strength Training + Maintenance Training

EXPERIMENTAL

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.

Device: Expiratory Muscle Strength Training; Device: Maintenance Training

Expiratory Muscle Strength Training

EXPERIMENTAL

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.

Device: Expiratory Muscle Strength Training

Interventions

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.

Also known as: EMST-150

Expiratory Muscle Strength Training; Expiratory Muscle Strength Training + Maintenance Training; Expiratory Muscle Strength Training + No Maintenance Training

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)

Expiratory Muscle Strength Training + Maintenance Training

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Noel Jabbour: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Conditions

Velopharyngeal Insufficiency; Cleft Palate; Speech Intelligibility

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Diseases; Stomatognathic System Abnormalities; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Speech; Verbal Behavior; Communication; Behavior

Study Officials

• Noel Jabbour, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber D Shaffer, PhD

CONTACT

412-692-6874; shafferad@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: March 3, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication of summary data. Ending 5 years after publication.
• Access Criteria: IPD will be shared with researchers who provide a methodologically sound proposal. IPD to be shared will include that necessary to achieve the aims in the approved proposal. Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement.

Locations

US (1)