TerminatedNot Applicable

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

Stopped: End of funding

United States11 participantsStarted 2019-08-16

Plain-language 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.

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Eustachian Tube Function at 2 Months

Timeframe: 2 months

Trial details

NCT IDNCT03868891

SponsorNoel Jabbour

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-06

Results submitted2023-04-05