Clinical trial Recruiting at 1 site Interventional Ages 5 to 17

Breathing exercises to improve speech in children with cleft palate

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

Run by University of Pittsburgh · NCT05492266 · Data updated 2026-11-12

This study is testing if breathing exercises can help children with cleft palate improve their speech by reducing nasal sounds.

More Velopharyngeal Insufficiency trials

Quick facts

Study typeInterventional
Ages5 Years to 17 Years
SexAll
Enrollment30 (estimated)
SponsorUniversity of Pittsburgh
Academic / other
Locations1 site (Pittsburgh, Pennsylvania)
StatusRecruiting
StartedMarch 3, 2025
Main results expectedMay 2027
Study endsNovember 2027
Registry record updatedJuly 20, 2026
Trial IDNCT05492266 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 5-17 years with a Pittsburgh weighted speech score of 5 or greater.

Probably not a fit

Patients with a hypernasality score below 2 or those who have had previous speech surgeries may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: While this approach is innovative, similar studies have shown promise in improving speech outcomes in children with related conditions.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.