Status:
TERMINATED
Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
Lead Sponsor:
Noel Jabbour
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Cleft Palate
Tube Disorders Eustachian
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief 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...
Detailed Description
This trial will look at the feasibility and effect of device-assisted soft palate exercises for the treatment of chronic Eustachian tube (ET) dysfunction (ETD) in older children still experiencing mid...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Concurrent or past diagnosis of cancer or history of radiation
- Have or had vestibular pathology, cranial base surgery or ossicular chain reconstruction
- Craniofacial dysmorphology (other than non-syndromic CP with or without cleft lip in the CP cohort) or other syndrome
- A non-patent nasal cavity
- Patulous ET or pathologically low ET opening or closing pressures
- Unable or unwilling to perform the tests and exercises outlined in the study
Key Trial Info
Start Date :
August 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03868891
Start Date
August 16 2019
End Date
May 31 2022
Last Update
June 23 2023
Active Locations (1)
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1
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224