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RECRUITING
NCT05492266
NA

Expiratory Muscle Strength Training for Hypernasal Speech in Children

Sponsor: Noel Jabbour

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-03-03

Completion Date

2027-11

Last Updated

2025-07-22

Healthy Volunteers

No

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)

Locations (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States