Velopharyngeal InsufficiencyNCT05492266
Expiratory Muscle Strength Training for Hypernasal Speech in Children
A study testing Expiratory Muscle Strength Training and Maintenance Training in people with Velopharyngeal Insufficiency and Velopharyngeal Incompetence Due to Cleft Palate, run by Noel Jabbour at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate, Inadequate Velopharyngeal Closure
- What is being tested?
- Expiratory Muscle Strength Training and Maintenance Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Score of 2 or greater on the nasality/resonance domain of the Pittsburgh Weighted Speech Scale
- Ages 5-17 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Amber D Shaffer, PhD, 412-692-6874, shafferad@upmc.edu
Marina V Rushchak, BA, 412-692-9879, rushchakmv4@upmc.edu
About this study
Official title: Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial
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.
Read the detailed 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 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.
- Conditions
- Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate, Inadequate Velopharyngeal Closure, Palatopharyngeal Incompetence, Hypernasality
- Being tested
- Expiratory Muscle Strength Training, Maintenance Training
- Keywords
- Cleft Palate, Speech Intelligibility
- Medical subject headings
- Velopharyngeal Insufficiency, Cleft Palate, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Muscle Strength TrainingDevice
Also called EMST-150
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.
Maintenance TrainingDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Expiratory Muscle Strength Training + No Maintenance Training | Experimental | 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. Receives: Device: Expiratory Muscle Strength Training |
| Expiratory Muscle Strength Training + Maintenance Training | Experimental | 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. Receives: Device: Expiratory Muscle Strength Training; Device: Maintenance Training |
| Expiratory Muscle Strength Training | Experimental | 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. Receives: Device: Expiratory Muscle Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasalance scores after 6-8 weeks of exercises compared with baseline
Percent change in nasalance measured during nasometry
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 6-8 weeks
Secondary outcomes (5)
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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: Baseline and 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start3 Mar 2025
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Velopharyngeal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noel Jabbour
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Noel Jabbour, University of Pittsburgh
- Investigators
- Noel Jabbour, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492266
- Sponsor's protocol ID
- STUDY21120032
- Other IDs
- 5R21DC017553-03
- Status last verified
- Jul 2026
- First submitted
- 4 Aug 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in a publication may be shared, after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT05492266
- Acronym / sponsor ID
- STUDY21120032
- Conditions
- Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate, Inadequate Velopharyngeal Closure, Palatopharyngeal Incompetence, Hypernasality
- Keywords
- Cleft Palate, Speech Intelligibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Noel JabbourUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expiratory Muscle Strength Training + No Maintenance Training | Experimental | Device: Expiratory Muscle Strength TrainingThese 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. |
| Expiratory Muscle Strength Training + Maintenance Training | Experimental | Device: Expiratory Muscle Strength Training, Device: Maintenance TrainingThese 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. |
| Expiratory Muscle Strength Training | Experimental | Device: Expiratory Muscle Strength TrainingThese 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Score of 2 or greater on the nasality/resonance domain of the Pittsburgh Weighted Speech Scale
- Ages 5-17 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expiratory Muscle Strength TrainingAlso: EMST-150At 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 | Expiratory Muscle Strength Training, Expiratory Muscle Strength Training + Maintenance Training, Expiratory Muscle Strength Training + No Maintenance Training |
| Maintenance TrainingAt 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) | Device | Expiratory Muscle Strength Training + Maintenance Training |
Primary outcome
Change in nasalance scores after 6-8 weeks of exercises compared with baseline
Time frame: Baseline and 6-8 weeks
Percent change in nasalance measured during nasometry
Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline
Time frame: Baseline and 6-8 weeks
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.
Change in oral pressure following 6-8 weeks of exercises compared with baseline
Time frame: Baseline and 6-8 weeks
Percent change in oral pressure achieved when blowing through the EMST-150
Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline
Time frame: Baseline and 6-8 weeks
Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150
Change in oral pressure decay following 6-8 weeks of exercises compared with baseline
Time frame: Baseline and 6-8 weeks
Ratio of the magnitude of oral pressure decay when blowing through the EMST-150
5 secondary outcomes
Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline
Time frame: Baseline and 6-8 weeks
Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline.
Time frame: Baseline and 6-8 weeks
Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline.
Time frame: Baseline and 6-8 weeks
Resolution of effusion following 6-8 weeks of exercises compared with baseline.
Time frame: Baseline and 6-8 weeks
Resolution of retraction following 6-8 weeks of exercises compared with baseline.
Time frame: Baseline and 6-8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in a publication may be shared, after de-identification.
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Effect of Velopharyngeal Gap Size on Laryngeal Morphology and Vocal Function in Children With VPI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noel Jabbour, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory Muscle Strength Training and Maintenance Training in people with Velopharyngeal Insufficiency and Velopharyngeal Incompetence Due to Cleft Palate, run by Noel Jabbour at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber D Shaffer, PhD (412-692-6874, shafferad@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nasalance scores after 6-8 weeks of exercises compared with baseline (time frame: Baseline and 6-8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.