Expiratory Muscle Strength Training for Hypernasal Speech in Children

Noel Jabbour

Status: Enrolling

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

Treatments: Device: Expiratory Muscle Strength Training; Device: Maintenance Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05492266

STUDY21120032

5R21DC017553-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

Expiratory Muscle Strength Training + No Maintenance Training

Experimental group

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.

Treatment:

Device: Expiratory Muscle Strength Training

No Exercises

No Intervention group

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.

Expiratory Muscle Strength Training + Maintenance Training

Experimental group

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.

Treatment:

Device: Maintenance Training

Device: Expiratory Muscle Strength Training

Expiratory Muscle Strength Training

Experimental group

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.

Treatment:

Device: Expiratory Muscle Strength Training