Expiratory Muscle Strength Training for Hypernasal Speech in Children

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Velopharyngeal Incompetence Due to Cleft Palate; Velopharyngeal Insufficiency; Palatopharyngeal Incompetence; Inadequate Velopharyngeal Closure; Hypernasality
• Intervention / Treatment: Device: Expiratory Muscle Strength Training; Device: Maintenance Training

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 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 (3-6 or 7+) to Expiratory Muscle Strength Training for 6 to 8 weeks or no exercises. Patients with reductions in PWSS during this time will be further randomized to EMST maintenance training for 6 months or no exercises.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amber D Shaffer, PhD; Phone Number: 412-692-6874; Email: shafferad@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh
      • Sub-Investigator: Cuneyt Alper, MD
      • Sub-Investigator: Daniel Awad, MS
      • Sub-Investigator: Matthew Ford, MS
      • Sub-Investigator: Jesse Goldstein, MD
      • Sub-Investigator: Joseph Losee, MD
      • Contact: Amber D Shaffer, PhD; Phone Number: 412-692-6874; Email: shafferad@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pittsburgh weighted speech scores of 3 or greater
• Ages 5-17 years

Exclusion Criteria:

• Previous speech surgery (e.g. palatoplasty or pharyngeal flap)
• Speech surgery scheduled within the next 56 days
• Unable or unwilling to perform the tests and exercises outlined in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expiratory Muscle Strength Training + No Maintenance Training; These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their speech score of 2 points or more and were randomized to complete 6 months of no maintenance training.	Device: Expiratory Muscle Strength Training; At visit 1, participants will be block randomized based on PWSS score (3-6 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.; Other Names: EMST-150
No Intervention: No Exercises; 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.
Experimental: Expiratory Muscle Strength Training + Maintenance Training; These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their speech score of 2 points or more and were randomized to complete 6 months of maintenance training.	Device: Expiratory Muscle Strength Training; At visit 1, participants will be block randomized based on PWSS score (3-6 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.; Other Names: EMST-150; Device: Maintenance Training; At visit 2, participants with improved (decreased) PWSS of 2 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)
Experimental: Expiratory Muscle Strength Training; These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They did not have improvement in their speech score of 2 points or more and ended active study participation after the initial 6-8 weeks of exercises.	Device: Expiratory Muscle Strength Training; At visit 1, participants will be block randomized based on PWSS score (3-6 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.; Other Names: EMST-150

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence	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

Collaborators and Investigators

• Sponsor: Noel Jabbour
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Noel Jabbour, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cleft Palate; Speech Intelligibility
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Velopharyngeal Insufficiency
• Other Study ID Numbers: STUDY21120032; 5R21DC017553-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie the results reported in a publication may be shared, after de-identification.
• IPD Sharing Time Frame: Beginning 1 year after publication of summary data. Ending 5 years after publication.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No