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.
Score of 2 or greater on the nasality/resonance domain of the Pittsburgh Weighted Speech Scale
Ages 5-17 years
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
Sequential
Expiratory Muscle Strength Training
DeviceAt 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 Training
DeviceAt 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
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.
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
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
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
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).
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).
Resolution of effusion following 6-8 weeks of exercises compared with baseline.
Percentage of participants with resolution of middle ear effusion based on otoscopy.
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
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.
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
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
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Noel Jabbour
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
