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Clinical Trial 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.


Clinical Trial Description

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 randomized, controlled trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. Patients will be block randomized based on Pittsburgh Weighted Speech Scale (PWSS) score (3-6 or 7+) to Expiratory Muscle Strength Training for 6 to 8 weeks or no exercises. Patients with reductions in PWSS during this time will be further randomized to EMST maintenance training for 6 months or no exercises. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05492266
Study type Interventional
Source University of Pittsburgh
Contact Amber D Shaffer, PhD
Phone 412-692-6874
Email shafferad@upmc.edu
Status Not yet recruiting
Phase N/A
Start date February 2024
Completion date September 2025

See also
  Status Clinical Trial Phase
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Completed NCT06343623 - Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure N/A
Recruiting NCT06072495 - Etiological Study of Persistent Velopharyngeal Insufficiency in Children With Operated Velopalatine Cleft by Analysis of Velopharyngeal Motor Skills in Static and Dynamic MRI N/A
Recruiting NCT05626933 - Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI N/A
Terminated NCT00213343 - Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration N/A
Terminated NCT02701322 - Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder N/A
Not yet recruiting NCT03469973 - Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction
Recruiting NCT03187600 - Submucosa/Mucosal Pharyngeal Flap Trial N/A
Completed NCT04009811 - A New Membrane Obturator Prothesis Concept for Soft Palate Defects N/A
Completed NCT04392817 - Efficacy of an Arabic Articulatory Error Remediation Software Program in Patients With Velopharyngeal Valve Dysfunction: N/A
Recruiting NCT05820529 - Effect of Adenotonsillectomy on Velopharyngeal Valve Mechanism N/A
Terminated NCT03868891 - Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate N/A