Breathing exercises to improve speech in children with cleft palate
Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial
NA · University of Pittsburgh · NCT05492266
This study is testing if breathing exercises can help children with cleft palate improve their speech by reducing nasal sounds.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05492266 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of expiratory muscle strength training (EMST) in enhancing velopharyngeal closure in children with velopharyngeal dysfunction, particularly those experiencing hypernasality due to conditions like cleft palate. Conducted at a specialized cleft craniofacial center, the trial will involve a randomized, controlled design where participants will either engage in EMST for 6 to 8 weeks or receive no exercises. Following this initial phase, those showing improvement in nasal resonance will be further randomized to maintenance training or no exercises for an additional 6 months.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-17 years with a Pittsburgh weighted speech score of 5 or greater.
Not a fit: Patients with a hypernasality score below 2 or those who have had previous speech surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve speech intelligibility and quality of life for children with velopharyngeal insufficiency.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving speech outcomes in children with related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pittsburgh weighted speech scores of 5 or greater * Ages 5-17 years Exclusion Criteria: * 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
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Noel Jabbour, MD — University of Pittsburgh
- Study coordinator: Amber D Shaffer, PhD
- Email: shafferad@upmc.edu
- Phone: 412-692-6874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate, Inadequate Velopharyngeal Closure, Palatopharyngeal Incompetence, Hypernasality, Cleft Palate, Speech Intelligibility