Expiratory Muscle Strength Training for Hypernasal Speech in Children

Conditions

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

Eligibility Criteria

Sex

ALL

Age

5 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Expiratory Muscle Strength Training — 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 — 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)

Study Details

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.

Key Dates

Start date

Mar 3, 2025

Status verified

Jul 2025

Primary completion

May 31, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• No Intervention: 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.
• Experimental: 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.
• Experimental: 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.

Primary Outcome Measure

Change in nasalance scores after 6-8 weeks of exercises compared with baseline [ Time Frame: Baseline and 6-8 weeks ]

Central Contacts

• Amber D Shaffer, PhD
  412-692-6874
  [email protected]

Locations (1)

Find similar trials in Pittsburgh, PA

Related Studies

• Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
  Recruiting · Vanessa Torrecillas · Charlottesville, Virginia