Clinical trial NCT05492266: Expiratory Muscle Strength Training for Hypernasal Speech in Children
Official title: Expiratory Muscle Strength Training As a Non-surgical Option for Velopharyngeal Dysfunction: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Velopharyngeal Insufficiency
Velopharyngeal Incompetence Due to Cleft Palate
Inadequate Velopharyngeal Closure
Palatopharyngeal Incompetence
Hypernasality
Keywords: Cleft Palate
Speech Intelligibility
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2022-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in nasalance scores after 6-8 weeks of exercises compared with baseline
timeFrame: Baseline and 6-8 weeks
measure: Change in perceptual speech symptoms of velopharyngeal dysfunction following 6-8 weeks of exercises compared with baseline
timeFrame: Baseline and 6-8 weeks
measure: Change in oral pressure following 6-8 weeks of exercises compared with baseline
timeFrame: Baseline and 6-8 weeks
measure: Change in velopharyngeal flutter following 6-8 weeks of exercises compared with baseline
timeFrame: Baseline and 6-8 weeks
measure: Change in oral pressure decay following 6-8 weeks of exercises compared with baseline
timeFrame: Baseline and 6-8 weeks
Secondary outcomes:
measure: Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline
timeFrame: Baseline and 6-8 weeks
measure: Resolution of type B tympanogram following 6-8 weeks of exercises compared with baseline.
timeFrame: Baseline and 6-8 weeks
measure: Resolution of type C tympanogram following 6-8 weeks of exercises compared with baseline.
timeFrame: Baseline and 6-8 weeks
measure: Resolution of effusion following 6-8 weeks of exercises compared with baseline.
timeFrame: Baseline and 6-8 weeks
measure: Resolution of retraction following 6-8 weeks of exercises compared with baseline.
timeFrame: Baseline and 6-8 weeks
Other outcomes:
measure: Change in nasalance scores after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
timeFrame: 6-8 weeks and 8 months
measure: Change in perceptual speech symptoms of velopharyngeal dysfunction after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
timeFrame: 6-8 weeks and 8 months
measure: Change in oral pressure after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
timeFrame: 6-8 weeks and 8 months
measure: Change in velopharyngeal flutter after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
timeFrame: 6-8 weeks and 8 months
measure: Change in oral pressure decay after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises
timeFrame: 6-8 weeks and 8 months
measure: Prevalence of surgical intervention
timeFrame: 1 year
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Noel Jabbour, MD
role: PRINCIPAL_INVESTIGATOR
References: