Hypernasality, Inadequate Velopharyngeal Closure, Palatopharyngeal Incompetence, Velopharyngeal Incompetence Due to Cleft Palate, Velopharyngeal Insufficiency
Conditions
Keywords
Cleft Palate, Speech Intelligibility
Brief 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.
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.
Interventions
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.
DEVICEMaintenance Training
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)
Sponsors
Noel Jabbour
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in nasalance scores after 6-8 weeks of exercises compared with baseline | 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 | 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 | 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 | 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 | Baseline and 6-8 weeks | Ratio of the magnitude of oral pressure decay when blowing through the EMST-150 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline | Baseline and 6-8 weeks | Percent change in Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) scores. Scores range from 0 - 100, with 100 representing the highest QOL |
| Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline. | Baseline and 6-8 weeks | Percentage of participants with a change in tympanogram type from type B (flat) to type A (normal middle ear function). |
| Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline. | Baseline and 6-8 weeks | Percentage of participants with a change in tympanogram type from type C (negative pressure) to type A (normal middle ear function). |
| Resolution of effusion following 6-8 weeks of exercises compared with baseline. | Baseline and 6-8 weeks | Percentage of participants with resolution of middle ear effusion based on otoscopy. |
| Resolution of retraction following 6-8 weeks of exercises compared with baseline. | Baseline and 6-8 weeks | Percentage of participants with resolution of tympanic membrane retraction based on otoscopy |
Countries
United States
Contacts
CONTACTAmber D Shaffer, PhD
PRINCIPAL_INVESTIGATORNoel Jabbour, MD
University of Pittsburgh
Outcome results
None listed