Expiratory Muscle Strength Training for Hypernasal Speech in Children

NCT ID: NCT05492266

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2027-11-30

Brief 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.

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 (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.

Conditions

Velopharyngeal Insufficiency; Velopharyngeal Incompetence Due to Cleft Palate; Inadequate Velopharyngeal Closure; Palatopharyngeal Incompetence; Hypernasality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 CAPS-A hypernasality rating of 1 point or more and were randomized to complete 6 months of no maintenance training.

Group Type: EXPERIMENTAL

Expiratory Muscle Strength Training

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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 CAPS-A hypernasality rating of 1 point or more and were randomized to complete 6 months of maintenance training.

Group Type: EXPERIMENTAL

Expiratory Muscle Strength Training

Intervention Type: 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.

Maintenance Training

Intervention Type: 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)

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 CAPS-A hypernasality rating of 1 point or more and ended active study participation after the initial 6-8 weeks of exercises.

Group Type: EXPERIMENTAL

Expiratory Muscle Strength Training

Intervention Type: 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.

Interventions

Expiratory Muscle Strength Training

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.

Intervention Type: DEVICE

Maintenance Training

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)

Intervention Type: DEVICE

Other Intervention Names

EMST-150

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• CAPS-A-AM hypernasality score <2
• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Noel Jabbour

OTHER

Sponsor Role: lead

Responsible Party

Noel Jabbour

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Noel Jabbour, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amber D Shaffer, PhD

Role: CONTACT

shafferad@upmc.edu

412-692-6874

Facility Contacts

Amber D Shaffer, PhD

Role: primary

shafferad@upmc.edu

412-692-6874

Marina V Rushchak, BA

Role: backup

rushchakmv4@upmc.edu

412-692-9879

Other Identifiers

5R21DC017553-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21120032

Identifier Type: -

Identifier Source: org_study_id