What side effects are associated with this type of intervention?

Common side effects of treatments for Velopharyngeal Insufficiency (VPI), such as soft palate exercises using a hand-held breathing device, include temporary discomfort or soreness in the muscles of the soft palate, mild fatigue, and potential initial difficulty in performing the exercises correctly. Some patients might also experience minor nasal congestion or irritation. These side effects are typically mild and transient.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Velopharyngeal Insufficiency (VPI) in the provided context. The study referenced involves soft palate exercises using a hand-held breathing device to improve muscle strength and function, but it does not indicate prior FDA approvals for similar treatments. Generally, treatments for VPI may include surgical interventions, speech therapy, and the use of prosthetic devices, but specific FDA-approved drugs or devices for muscle strengthening of the soft palate in VPI are not detailed in the provided information.

What other types of research exist?

Promising alternatives to soft palate exercises using a hand-held breathing device for VPI patients include the use of palatal lift and palatal augmentation prostheses. These dental prostheses can help maximize oral rehabilitation by supporting weak or paralyzed oral musculature, improving speech articulation, and reducing nasal emission and hypernasality. Additionally, noninvasive ventilatory support and mechanical insufflation-exsufflation devices may also offer benefits for patients with respiratory muscle dysfunction, which can be relevant for those with VPI.

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Behavioural Intervention

Expiratory Muscle Strength Training for Hypernasal Speech

N/A

Waitlist Available

Led By Noel Jabbour, MD

Research Sponsored by Noel Jabbour

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if breathing exercises with a small device can help people with speech problems caused by a cleft palate or similar issues. The exercises aim to make the muscles stronger so that the soft palate can close better, improving speech.

Who is the study for?

This trial is for children aged 5-17 with a speech difference called velopharyngeal insufficiency, often due to cleft palate. They should have noticeable speech issues (score of 3 or higher on a specific scale) and must be able to do the exercises in the study. Kids who've had previous speech surgery or have one scheduled within two months can't join.

What is being tested?

The study tests if using a handheld breathing device for soft palate exercises can improve the closing function between throat and nose, potentially enhancing speech quality in kids with velopharyngeal insufficiency.

What are the potential side effects?

Potential side effects are not specified but may include discomfort from using the breathing device, fatigue from performing exercises, or soreness in muscles involved in training.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in nasalance scores after 6-8 weeks of exercises compared with baseline

Change in oral pressure decay following 6-8 weeks of exercises compared with baseline

Change in oral pressure following 6-8 weeks of exercises compared with baseline

+2 more

Secondary study objectives

Change in VELO questionnaire scores following 6-8 weeks of exercises compared with baseline

Resolution of effusion following 6-8 weeks of exercises compared with baseline.

Resolution of retraction following 6-8 weeks of exercises compared with baseline.

+2 more

Other study objectives

Change in nasalance scores after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

Change in oral pressure after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

Change in oral pressure decay after 6 months of maintenance exercises compared with after the initial 6-8 weeks of exercises

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Expiratory Muscle Strength Training + No Maintenance TrainingExperimental Treatment1 Intervention

These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They had improvement in their speech score of 2 points or more and were randomized to complete 6 months of no maintenance training.

Group II: Expiratory Muscle Strength Training + Maintenance TrainingExperimental Treatment2 Interventions

Group III: Expiratory Muscle Strength TrainingExperimental Treatment1 Intervention

These participants were initially randomized to complete 6-8 weeks of exercises with EMST-150. They did not have improvement in their speech score of 2 points or more and ended active study participation after the initial 6-8 weeks of exercises.

Group IV: No ExercisesActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Expiratory Muscle Strength Training

2016

N/A

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Velopharyngeal insufficiency (VPI) treatments often focus on strengthening the soft palate muscles to improve their ability to close the gap between the throat and nose during speech. Exercises using hand-held breathing devices are designed to enhance the strength and coordination of these muscles, which is essential for reducing hypernasal speech and improving speech clarity. This non-invasive approach directly targets the muscle weakness that causes VPI, offering a practical solution for patients to achieve better speech outcomes.

The Effect of Lingual Resistance Training Interventions on Adult Swallow Function: A Systematic Review.