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Behavioural Intervention
EMST150 for 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
- Cleft Palate
- Nasal speech
- Palatopharyngeal Dysfunction
- Eustachian Tube Dysfunction
- Velopharyngeal Insufficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months and 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months and 4 months
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 moreAwards & 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 Cleft Palate
30 Patients Enrolled for Cleft Palate
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
352 Previous Clinical Trials
181,178 Total Patients Enrolled
3 Trials studying Cleft Palate
195 Patients Enrolled for Cleft Palate
Noel Jabbour, MD, MSPrincipal InvestigatorUniversity of Pittsburgh
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