Recruiting

Expiratory Muscle Strength Training

Sponsor:

Noel Jabbour

Code:

NCT05492266

Conditions

Velopharyngeal Insufficiency

Velopharyngeal Incompetence Due to Cleft Palate

Inadequate Velopharyngeal Closure

Palatopharyngeal Incompetence

Hypernasality

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Expiratory Muscle Strength Training

Maintenance Training

Study Details

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

Study ID

NCT05492266

Start date

Mar 3, 2025

Status verified date

Jul, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Expiratory Muscle Strength Training + No Maintenance Training

These participants completed 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.

experimental: Expiratory Muscle Strength Training + Maintenance Training

These participants completed 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.

experimental: Expiratory Muscle Strength Training

These participants completed 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.

Interventions

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.

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 measure

  • Change in nasalance scores after 6-8 weeks of exercises compared with baseline [ Time Frame: Baseline and 6-8 weeks ]
  • Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline [ Time Frame: Baseline and 6-8 weeks ]
  • Change in oral pressure following 6-8 weeks of exercises compared with baseline [ Time Frame: Baseline and 6-8 weeks ]
  • Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline [ Time Frame: Baseline and 6-8 weeks ]
  • Change in oral pressure decay following 6-8 weeks of exercises compared with baseline [ Time Frame: Baseline and 6-8 weeks ]

Central Contacts and Locations

Central contacts

Amber D Shaffer, PhD

412-692-6874shafferad@upmc.edu

Locations

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Amber D Shaffer, PhD

412-692-6874shafferad@upmc.edu

Marina V Rushchak, BA

412-692-9879rushchakmv4@upmc.edu

Principal Investigator:

Noel Jabbour, MD

More Information

Sponsor

Noel Jabbour

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Cleft Palate
  • Speech Intelligibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Noel Jabbour on 2026-07-20.