Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-28 @ 10:53 AM
Study NCT ID:
NCT05492266
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2022-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expiratory Muscle Strength Training for Hypernasal Speech in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014681', 'term': 'Velopharyngeal Insufficiency'}, {'id': 'D002972', 'term': 'Cleft Palate'}, {'id': 'D013065', 'term': 'Speech Intelligibility'}], 'ancestors': [{'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D013060', 'term': 'Speech'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in nasalance scores after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises', 'timeFrame': '6-8 weeks and 8 months', 'description': 'Percent change in nasalance measured during nasometry'}, {'measure': 'Change in perceptual speech symptoms of velopharyngeal dysfunction after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises', 'timeFrame': '6-8 weeks and 8 months', 'description': '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.'}, {'measure': 'Change in oral pressure after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises', 'timeFrame': '6-8 weeks and 8 months', 'description': 'Percent change in pressure achieved when blowing through the EMST-150'}, {'measure': 'Change in velopharyngeal flutter after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises', 'timeFrame': '6-8 weeks and 8 months', 'description': 'Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150'}, {'measure': 'Change in oral pressure decay after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises', 'timeFrame': '6-8 weeks and 8 months', 'description': 'Ratio of the magnitude of oral pressure decay when blowing through the EMST-150'}, {'measure': 'Prevalence of surgical intervention', 'timeFrame': '1 year', 'description': 'Percentage of patients undergoing surgical intervention for speech symptoms within the 1 year following enrollment'}], 'primaryOutcomes': [{'measure': 'Change in nasalance scores after 6-8 weeks of exercises compared with baseline', 'timeFrame': 'Baseline and 6-8 weeks', 'description': 'Percent change in nasalance measured during nasometry'}, {'measure': 'Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline', 'timeFrame': 'Baseline and 6-8 weeks', 'description': '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.'}, {'measure': 'Change in oral pressure following 6-8 weeks of exercises compared with baseline', 'timeFrame': 'Baseline and 6-8 weeks', 'description': 'Percent change in oral pressure achieved when blowing through the EMST-150'}, {'measure': 'Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline', 'timeFrame': 'Baseline and 6-8 weeks', 'description': 'Change in percentage of participants with oscillating oral pressure when blowing through the EMST-150'}, {'measure': 'Change in oral pressure decay following 6-8 weeks of exercises compared with baseline', 'timeFrame': 'Baseline and 6-8 weeks', 'description': 'Ratio of the magnitude of oral pressure decay when blowing through the EMST-150'}], 'secondaryOutcomes': [{'measure': 'Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline', 'timeFrame': 'Baseline and 6-8 weeks', 'description': 'Percent change in Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) scores. Scores range from 0 - 100, with 100 representing the highest QOL'}, {'measure': 'Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline.', 'timeFrame': 'Baseline and 6-8 weeks', 'description': 'Percentage of participants with a change in tympanogram type from type B (flat) to type A (normal middle ear function).'}, {'measure': 'Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline.', 'timeFrame': 'Baseline and 6-8 weeks', 'description': 'Percentage of participants with a change in tympanogram type from type C (negative pressure) to type A (normal middle ear function).'}, {'measure': 'Resolution of effusion following 6-8 weeks of exercises compared with baseline.', 'timeFrame': 'Baseline and 6-8 weeks', 'description': 'Percentage of participants with resolution of middle ear effusion based on otoscopy.'}, {'measure': 'Resolution of retraction following 6-8 weeks of exercises compared with baseline.', 'timeFrame': 'Baseline and 6-8 weeks', 'description': 'Percentage of participants with resolution of tympanic membrane retraction based on otoscopy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cleft Palate', 'Speech Intelligibility'], 'conditions': ['Velopharyngeal Insufficiency', 'Velopharyngeal Incompetence Due to Cleft Palate', 'Inadequate Velopharyngeal Closure', 'Palatopharyngeal Incompetence', 'Hypernasality']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pittsburgh weighted speech scores of 5 or greater\n* Ages 5-17 years\n\nExclusion Criteria:\n\n* CAPS-A-AM hypernasality score \\<2\n* Previous speech surgery (e.g. palatoplasty or pharyngeal flap)\n* Speech surgery scheduled within the next 56 days\n* Unable or unwilling to perform the tests and exercises outlined in the study'}, 'identificationModule': {'nctId': 'NCT05492266', 'briefTitle': 'Expiratory Muscle Strength Training for Hypernasal Speech in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY21120032'}, 'secondaryIdInfos': [{'id': '5R21DC017553-03', 'link': 'https://reporter.nih.gov/quickSearch/5R21DC017553-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expiratory Muscle Strength Training + No Maintenance Training', 'description': '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.', 'interventionNames': ['Device: Expiratory Muscle Strength Training']}, {'type': 'NO_INTERVENTION', 'label': 'No Exercises', 'description': '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.'}, {'type': 'EXPERIMENTAL', 'label': 'Expiratory Muscle Strength Training + Maintenance Training', 'description': '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.', 'interventionNames': ['Device: Expiratory Muscle Strength Training', 'Device: Maintenance Training']}, {'type': 'EXPERIMENTAL', 'label': 'Expiratory Muscle Strength Training', 'description': '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.', 'interventionNames': ['Device: Expiratory Muscle Strength Training']}], 'interventions': [{'name': 'Expiratory Muscle Strength Training', 'type': 'DEVICE', 'otherNames': ['EMST-150'], 'description': '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.', 'armGroupLabels': ['Expiratory Muscle Strength Training', 'Expiratory Muscle Strength Training + Maintenance Training', 'Expiratory Muscle Strength Training + No Maintenance Training']}, {'name': 'Maintenance Training', 'type': 'DEVICE', 'description': '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)', 'armGroupLabels': ['Expiratory Muscle Strength Training + Maintenance Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amber D Shaffer, PhD', 'role': 'CONTACT', 'email': 'shafferad@upmc.edu', 'phone': '412-692-6874'}, {'name': 'Marina V Rushchak, BA', 'role': 'CONTACT', 'email': 'rushchakmv4@upmc.edu', 'phone': '412-692-9879'}, {'name': 'Cuneyt Alper, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fendi Obuekwe', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthew Ford, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jesse Goldstein, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nancy Gauvin, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Noel Jabbour, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "UPMC Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Amber D Shaffer, PhD', 'role': 'CONTACT', 'email': 'shafferad@upmc.edu', 'phone': '412-692-6874'}], 'overallOfficials': [{'name': 'Noel Jabbour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 1 year after publication of summary data. Ending 5 years after publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie the results reported in a publication may be shared, after de-identification.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noel Jabbour', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Noel Jabbour', 'investigatorAffiliation': 'University of Pittsburgh'}}}}