Expiratory Muscle Strength Training for Hypernasal Speech in Children

Velopharyngeal Insufficiency Clinical Trial

Official title:

Expiratory Muscle Strength Training as a Non-surgical Option for Velopharyngeal Dysfunction: A Randomized-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05492266
• Other study ID #: STUDY21120032
• Secondary ID: 5R21DC017553-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Amber D Shaffer, PhD
• Phone: 412-692-6874
• Email: shafferad[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate
• Hypernasality
• Velopharyngeal Incompetence Due to Cleft Palate
• Velopharyngeal Insufficiency

Intervention

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.
• 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)

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Noel Jabbour	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Prevalence of surgical intervention	Percentage of patients undergoing surgical intervention for speech symptoms within the 1 year following enrollment	1 year
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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