Previous studies performed in our laboratory have identified functional variables and examined their effects on Eustachian tube (ET) opening. Specifically, frame-by-frame image analysis of nasopharyngeal (NP) video endoscopy recorded during swallows has demonstrated that 1) higher soft palate elevation, 2) longer duration of soft palate elevation and delay in relaxation, 3) larger rotation of the ET posterior lamina secondary to soft palate elevation and 4) a wider angle between the posterior and anterior laminas are associated with more effective ET opening and improved middle-ear pressure equilibration. These observations imply that soft palate elevation and levator veli palatini muscle (mLVP) contraction may have a more important role than previously thought. The association between ET dysfunction (ETD) and velopharyngeal (VP) insufficiency secondary to submucous cleft or cleft palate (CP), even after surgical repair, is well known. In the proposed pilot study, we hypothesize that children older than 5 years with or without CP with ongoing need for ventilation tubes (VT) for treatment of otitis media with effusion and tympanic membrane (TM) retraction/retraction pocket have ETD related to the mechanisms and effectiveness in elevating the soft palate during speech and swallowing. Therefore, modifying and enhancing soft palate elevation may improve ET function (ETF). Specifically, this is a prospective randomized trial in which children 6-17 years of age, with (n=15) and without (n=15) CP, who have ETD and at least one functional VT or TM perforation, will be randomly assigned to use one of two palatal exercise devices: the EarPopper or the EMST150. The devices will be used for 2 months. Prior to randomization, ETF testing and static/dynamic video-endoscopy of the NP ET orifice will be done at the Middle Ear Physiology Laboratory at Children?s Hospital of Pittsburgh (CHP). Subjects will also undergo a clinical swallow and speech evaluation by the PI and Speech Pathologist of the Cleft Palate Craniofacial Center at CHP, including complete craniofacial exam, video-analysis of soft palate elevation, and perceptual speech evaluation. These tests will be repeated at the completion of the exercise period (2 months) and again 2 months after completing the exercises (4 months). The primary outcome measures are the results of VP competence, specifically, the ability to have better and longer soft palate closure, and the ability to have better active muscular function on ETF testing. This proposal explores a new targeted non-surgical treatment modality for ETD, providing estimates of feasibility and magnitude of effect. This preliminary data will help develop specific testable hypotheses and sample size estimates for future clinical trials.
Many children older than 5 years continue to have middle-ear disease after the supposed age of Eustachian tube function maturation without effective non-surgical treatment options. This is a prospective randomized pilot study of the feasibility and effect of soft-palate exercises for the treatment of Eustachian tube dysfunction in children 6-17 years of age with (n=15) and without (n=15) cleft palate. This preliminary data will help develop specific testable hypotheses and sample size estimates for future clinical trials.