Device Assisted Exercises for Improving Soft Palate and Eustachian Tube Function in Children Between Ages 6-17 With or Without Cleft Palate and With Ventilation Tubes

Trial Information
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
Summary

Elevation of the soft palate (the soft part of the roof of the mouth) during swallowing helps the Eustachian tube to open and keep the ear healthy. (The Eustachian tube is the normal tube running from the middle ear to the back of the nose and throat). When the soft palate does not move enough (due to a history of cleft palate or for unknown reasons), this can lead to speech problems. Also, because the Eustachian tube is not opening enough, fluid can accumulate in the middle ear, which requires treatment with ear tubes. The goal of this research study is to determine if soft palate exercises will help improve the ability of the soft palate to close the area between the throat and nose, like it is supposed to during speech and swallowing, and if this improves Eustachian tube opening.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
6
Maximum Age:
17
Healthy Volunteers:
No

• 6-17 years old

• Otherwise healthy

• Currently have unilateral or bilateral ventilation tube(s) (VTs) inserted for otitis media with effusion (OME) or tympanic membrane retraction/retraction pocket (TM-R/RP) or a TM perforation after extrusion of a VT

• History of at least 2 sets of VT insertions in the past

• Eustachian tube (ET) function (ETF) tests showing an active muscular pattern of Eustachian tube dysfunction

• Some degree of velopharyngeal dysfunction during the ETF tests

• Cleft Palate (CP) cohort: non-syndromic; prior palatoplasty without complications or need for revision

• Non-CP cohort: have had prior adenoidectomy

Where is this trial taking place?
United States
Pennsylvania
UPMC Children's Hospital of Pittsburgh
Recruiting
Pittsburgh
When is this trial taking place?
Start Date: August 16, 2019
Estimated Completion Date: June 2022
How many participants will be in this trial?
Target number of participants: 30
What treatment is being studied in this trial?
Experimental: EMST150
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
Who are the authors of this trial?

This content was sourced from clinicaltrials.gov

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