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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DC017553-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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 randomized, controlled trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. Patients will be block randomized based on Pittsburgh Weighted Speech Scale (PWSS) score (5-6 or 7+) to Expiratory Muscle Strength Training for 6 to 8 weeks or no exercises. Patients with reductions in nasal resonance during this time will be further randomized to EMST maintenance training for 6 months or no exercises.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expiratory Muscle Strength Training + No Maintenance Training | Experimental | These participants were initially randomized to complete 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. |
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| No Exercises | No Intervention | These participants were initially randomized to 6-8 weeks of no exercises. They ended active study participation after the initial 6-8 weeks of no exercises. They were not eligible to be randomized to maintenance training or no maintenance training. | |
| Expiratory Muscle Strength Training + Maintenance Training | Experimental | These participants were initially randomized to complete 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. |
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| Expiratory Muscle Strength Training | Experimental | These participants were initially randomized to complete 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expiratory Muscle Strength Training | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nasalance scores after 6-8 weeks of exercises compared with baseline | Percent change in nasalance measured during nasometry | 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. | 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 | 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 | 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 | Baseline and 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 6-8 weeks |
| Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amber D Shaffer, PhD | Contact | 412-692-6874 | shafferad@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Noel Jabbour, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
Individual participant data (IPD) that underlie the results reported in a publication may be shared, after de-identification.
Beginning 1 year after publication of summary data. Ending 5 years after publication.
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.
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| Maintenance Training | Device | 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) |
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Percentage of participants with a change in tympanogram type from type B (flat) to type A (normal middle ear function). |
| 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). | 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. | 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 | 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. |
| 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 | 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 | 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 | 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 | 1 year |
| ID | Term |
|---|---|
| D014681 | Velopharyngeal Insufficiency |
| D002972 | Cleft Palate |
| D013065 | Speech Intelligibility |
| ID | Term |
|---|---|
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010608 | Pharyngeal Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D010038 | Otorhinolaryngologic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D013060 | Speech |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
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