# 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

> **NIH NIH R21** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2020 · $153,534

## Abstract

PROJECT SUMMARY / ABSTRACT
 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.

## Key facts

- **NIH application ID:** 9842428
- **Project number:** 5R21DC017553-02
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Noel Jabbour
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $153,534
- **Award type:** 5
- **Project period:** 2019-01-01 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9842428

## Citation

> US National Institutes of Health, RePORTER application 9842428, 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 (5R21DC017553-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9842428. Licensed CC0.

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