An interventional study of Expiratory Muscle Strength Training and Maintenance Training in Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate and Inadequate Velopharyngeal Closure, sponsored by Noel Jabbour. Recruiting at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Noel Jabbour · Not applicable, Interventional, and Treatment
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.
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 single-arm trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. Patients will perform Expiratory Muscle Strength Training for 6 to 8 weeks. Patients with reductions in nasal resonance during this time will be further randomized to EMST maintenance training for 6 months or no exercises.
20 studies on the registry are indexed under Velopharyngeal Insufficiency; 9 are open to participants now.
This study's planned enrollment of 30 is above the median of 20 across 13 interventional studies indexed under Velopharyngeal Insufficiency.
Browse Velopharyngeal Insufficiency studies →Noel Jabbour is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Expiratory Muscle Strength 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.
Device: Expiratory Muscle Strength Training · Device: Maintenance 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.
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.
Also known as: EMST-150
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)
Change in nasalance scores after 6-8 weeks of exercises compared with baseline
Percent change in nasalance measured during nasometry
Time frame: Baseline and 6-8 weeks
Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline
Perceptual symptoms of velopharyngeal incompetence measured using the CAPS-A-AM hypernasality score, on a scale of 0-4. 0 indicates nasality that is normal for the region, 1 (borderline/minimal) suggests a minimal or inconsistent increase in nasal resonance, 2 (mild) implies hypernasality that is evident on vowels with a high tongue posture, 3 (moderate) indicates hypernasality that is perceived across all vowels, and 4 (severe) signifies that hypernasality is evident in voiced consonants and all vowels.
Time frame: Baseline and 6-8 weeks
Change in oral pressure following 6-8 weeks of exercises compared with baseline
Percent change in oral pressure achieved when blowing through the EMST-150
Time frame: Baseline and 6-8 weeks
Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline
Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150
Time frame: Baseline and 6-8 weeks
Change in oral pressure decay following 6-8 weeks of exercises compared with baseline
Ratio of the magnitude of oral pressure decay when blowing through the EMST-150
Time frame: Baseline and 6-8 weeks
Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline
Percent change in Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) scores. Scores range from 0 - 100, with 100 representing the highest QOL
Time frame: Baseline and 6-8 weeks
Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline.
Percentage of participants with a change in tympanogram type from type B (flat) to type A (normal middle ear function).
Time frame: Baseline and 6-8 weeks
Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline.
Percentage of participants with a change in tympanogram type from type C (negative pressure) to type A (normal middle ear function).
Time frame: Baseline and 6-8 weeks
Resolution of effusion following 6-8 weeks of exercises compared with baseline.
Percentage of participants with resolution of middle ear effusion based on otoscopy.
Time frame: Baseline and 6-8 weeks
Resolution of retraction following 6-8 weeks of exercises compared with baseline.
Percentage of participants with resolution of tympanic membrane retraction based on otoscopy
Time frame: Baseline and 6-8 weeks
Change in nasalance scores after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
Percent change in nasalance measured during nasometry
Time frame: 6-8 weeks and 8 months
Change in perceptual speech symptoms of velopharyngeal dysfunction after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
Perceptual symptoms of velopharyngeal incompetence measured using the CAPS-A-AM hypernasality score, on a scale of 0-4. 0 indicates nasality that is normal for the region, 1 (borderline/minimal) suggests a minimal or inconsistent increase in nasal resonance, 2 (mild) implies hypernasality that is evident on vowels with a high tongue posture, 3 (moderate) indicates hypernasality that is perceived across all vowels, and 4 (severe) signifies that hypernasality is evident in voiced consonants and all vowels.
Time frame: 6-8 weeks and 8 months
Change in oral pressure after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
Percent change in pressure achieved when blowing through the EMST-150
Time frame: 6-8 weeks and 8 months
Change in velopharyngeal flutter after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150
Time frame: 6-8 weeks and 8 months
Change in oral pressure decay after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
Ratio of the magnitude of oral pressure decay when blowing through the EMST-150
Time frame: 6-8 weeks and 8 months
Prevalence of surgical intervention
Percentage of patients undergoing surgical intervention for speech symptoms within the 1 year following enrollment
Time frame: 1 year
Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in a publication may be shared, after de-identification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning 1 year after publication of summary data. Ending 5 years after publication.
Access criteria: IPD will be shared with researchers who provide a methodologically sound proposal. IPD to be shared will include that necessary to achieve the aims in the approved proposal. Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement.
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for May 2027, 26 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Velopharyngeal Insufficiency →
Noel Jabbour