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Recruiting NCT05492266

Expiratory Muscle Strength Training for Hypernasal Speech in Children

No phase Interventional Velopharyngeal Insufficiency Velopharyngeal Incompetence Due to Cleft Palate Inadequate Velopharyngeal Closure Palatopharyngeal Incompetence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Expiratory Muscle Strength Training, Maintenance Training.
Who it may be relevant to
Registry conditions: Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate, Inadequate Velopharyngeal Closure, Palatopharyngeal Incompetence. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 single-arm trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. Patients will perform Expiratory Muscle Strength Training for 6 to 8 weeks. Patients with reductions in nasal resonance during this time will be further randomized to EMST maintenance training for 6 months or no exercises.

Interventions

  • Device 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.
  • 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)

Primary outcome measures

  • Change in nasalance scores after 6-8 weeks of exercises compared with baseline [Time frame: Baseline and 6-8 weeks]
  • Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline [Time frame: Baseline and 6-8 weeks]
  • Change in oral pressure following 6-8 weeks of exercises compared with baseline [Time frame: Baseline and 6-8 weeks]
  • Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline [Time frame: Baseline and 6-8 weeks]
  • Change in oral pressure decay following 6-8 weeks of exercises compared with baseline [Time frame: Baseline and 6-8 weeks]
Secondary outcome measures (5)
  • Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline [Time frame: Baseline and 6-8 weeks]
  • Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline. [Time frame: Baseline and 6-8 weeks]
  • Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline. [Time frame: Baseline and 6-8 weeks]
  • Resolution of effusion following 6-8 weeks of exercises compared with baseline. [Time frame: Baseline and 6-8 weeks]
  • Resolution of retraction following 6-8 weeks of exercises compared with baseline. [Time frame: Baseline and 6-8 weeks]

Eligibility criteria

Inclusion criteria

  • Score of 2 or greater on the nasality/resonance domain of the Pittsburgh Weighted Speech Scale
  • Ages 5-17 years

Exclusion criteria

  • CAPS-A-AM hypernasality score <2
  • Previous speech surgery (e.g. palatoplasty or pharyngeal flap for speech)
  • Speech surgery scheduled within the next 56 days
  • Unable or unwilling to perform the tests and exercises outlined in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UPMC Children's Hospital of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT05492266 · STUDY21120032 · 5R21DC017553-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗