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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

Study Summary

This trial is testing whether exercises using a hand-held device can improve speech in people with a cleft palate or other condition that prevents the soft palate from moving enough.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

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
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 maintenance training.
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

Find a Location

Who is running the clinical trial?

Noel JabbourLead Sponsor
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Velopharyngeal Insufficiency
11 Patients Enrolled for Velopharyngeal Insufficiency
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
327 Previous Clinical Trials
178,185 Total Patients Enrolled
1 Trials studying Velopharyngeal Insufficiency
11 Patients Enrolled for Velopharyngeal Insufficiency
Noel Jabbour, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Expiratory Muscle Strength Training (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05492266 — N/A
Velopharyngeal Insufficiency Research Study Groups: Expiratory Muscle Strength Training, Expiratory Muscle Strength Training + Maintenance Training, Expiratory Muscle Strength Training + No Maintenance Training, No Exercises
Velopharyngeal Insufficiency Clinical Trial 2023: Expiratory Muscle Strength Training Highlights & Side Effects. Trial Name: NCT05492266 — N/A
Expiratory Muscle Strength Training (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05492266 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ultimate aim is this research attempting to fulfill?

"This clinical trial's primary goal is to measure changes in oral pressure after 6-8 weeks of exercises when compared with the baseline. Secondary outcomes include resolution of retraction indicated by percentage change, transformation from type B tympanogram (flat) to A (normal middle ear function), and resolution of effusion through otoscopy."

Answered by AI

Are individuals aged 40 and up admissible to this research project?

"Consistent with the requirements for this research, participants must be between 5 and 17 years old."

Answered by AI

Does this clinical investigation have any openings for participants?

"Data posted on clinicaltrials.gov suggests that this trial is no longer actively seeking candidates; it was initially listed on November 1st 2022 and its most recent update came on September 9th of the same year. Nevertheless, there remain 15 other studies recruiting patients at present."

Answered by AI

Who are the eligible candidates for this research trial?

"This trial has a participant limit of 30 and is only open to those aged between 5 and 17 years old with velopharyngeal insufficiency."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Expiratory Muscle Strength Training for Hypernasal Speech in Children
Noel Jabbour 2024. "Expiratory Muscle Strength Training for Hypernasal Speech in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05492266.
~20 spots leftby Feb 2025
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