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Behavioural Intervention

Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate

N/A
Waitlist Available
Led By Noel Jabbour, MD, MS
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 2 months and 4 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if soft palate exercises using a device can help children with ear problems by improving the function of the soft palate and Eustachian tube. It focuses on kids aged 6-17 with chronic ear issues, including those with a history of cleft palate. The exercises aim to strengthen the soft palate to help it close properly, which can improve ear health.

Eligible Conditions
  • Velopharyngeal Insufficiency
  • Cleft Palate
  • Nasal speech
  • Eustachian Tube Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months and 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Eustachian Tube Function at 2 Months
Secondary study objectives
Eustachian Tube Function at 4 Months
Other study objectives
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EMST150Experimental Treatment1 Intervention
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.

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Who is running the clinical trial?

Noel JabbourLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Velopharyngeal Insufficiency
30 Patients Enrolled for Velopharyngeal Insufficiency
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
354 Previous Clinical Trials
181,724 Total Patients Enrolled
1 Trials studying Velopharyngeal Insufficiency
30 Patients Enrolled for Velopharyngeal Insufficiency
Noel Jabbour, MD, MSPrincipal InvestigatorUniversity of Pittsburgh
~2 spots leftby Dec 2025
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