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

Overview

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 using 1 or 2 devices 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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2021

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 middle-ear disease. Children with or without cleft palate (CP) with ventilation tubes (VTs) will be evaluated for the function of the soft palate and the ET. Subjects with active muscular ETD and inadequate soft palate closure will be prescribed soft palate strengthening exercises for at least 2 months. The objective of the study is to demonstrate the effect of exercises on soft palate closure and ETF. This pilot study will randomly assign 48 children between ages 6-17 years with VTs or post-VT extrusion tympanic membrane (TM) perforations to the Eustachi only, EMST150 only, or EMST150 + Eustachi group. All 48 children will have ETD, with active muscular dysfunction. 24 subjects will have a history of cleft palate (CP) and 24 no history of CP. Subjects will undergo history, physical examination including an ENT exam, videoendoscopy and ET function testing including Forced Response Test (FRT), Inflation-Deflation Test (IDT) and Tubomanometry. They will also undergo evaluations for swallow, speech and soft palate function. Enrolled children will then be randomized, within CP/non-CP groups and stratified by age (6-11 years, 12-17 years), to the Eustachi only, EMST150 only, or EMST150 + Eustachi group and receive instruction on the use of their assigned exercise device(s). This device will be used daily for at least 2 months. Subjects will undergo full evaluations for ET function and velopharyngeal incompetence after the 2-month treatment and will then discontinue the use of devices for at least 2 months. After this time, the same testing will be done. Weekly phone calls from study staff will encourage use of the devices as prescribed.

Interventions

  • Device: Eustachi
    • The Eustachi has a handle attached to a nose probe that delivers a constant airflow into the nose. The Eustachi is turned on and while one nostril is pinched with one finger, the nose probe is sealed in the other nostril. Your child will swallow 5 times and will complete an exercise diary recording whether a popping or pressure change was felt in the left, right, or both ears. This exercise sequence will be performed twice in each nostril 2 times a day until your child’s next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day.
  • Device: EMST150
    • The EMST150 consists of a handheld plastic tube with a mouthpiece on one end and an adjustable valve on the other end. Your child will close his/her lips around the mouthpiece and breathe out against resistance. The EMST150 will be adjusted to the point where airflow stops. Each day, your child will blow into the EMST150 5 sets of 5 times with a 10-15 second rest between each use and a 1-2 minute rest between each set of 5. You will adjust the resistance of the device each week, take a picture of the device settings, and document exercise sets performed in an exercise diary. These exercises will be performed twice in each nostril 2 times a day until your child’s next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day.

Arms, Groups and Cohorts

  • Active Comparator: Eustachi
    • Subjects with or without cleft palate will use the Eustachi 2 times a day for 8 weeks.
  • Active Comparator: EMST150
    • Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
  • Active Comparator: EMST150 + Esutachi
    • Subjects with or without cleft palate will use the EMST150 and Eustachi 2 times a day for 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Eustachian tube function after 2 months of exercise compared with baseline
    • Time Frame: Baseline and 2 months
    • Percent change in middle ear pressure during the inflation-deflation test (non-intact tympanic membranes) or pressure chamber (intact tympanic membrane)

Secondary Measures

  • Eustachian tube function after 2 months of rest compared with baseline
    • Time Frame: Baseline and 4 months
    • Percent change in middle ear pressure during the inflation-deflation test (non-intact tympanic membranes) or pressure chamber (intact tympanic membrane)
  • Velopharyngeal pressure after 2 months of exercise compared with baseline
    • Time Frame: Baseline and 2 months
    • Maximum pressure achieved during tubomanometry with respect to the delivered pressure (% max achieved)
  • Velopharyngeal pressure after 2 months of rest compared with baseline
    • Time Frame: Baseline and 4 months
    • Maximum pressure achieved during tubomanometry with respect to the delivered pressure (% max achieved)
  • Duration of velopharyngeal closure after 2 months of exercise compared with baseline
    • Time Frame: Baseline and 2 months
    • Duration of plateau (velopharyngeal closure phase) during tubomanometry
  • Duration of velopharyngeal closure after 2 months of rest compared with baseline
    • Time Frame: Baseline and 4 months
    • Duration of plateau (velopharyngeal closure phase) during tubomanometry
  • Ability to maintain velopharyngeal closure after 2 months of exercise compared with baseline
    • Time Frame: Baseline and 2 months
    • Amplitude of pressure change (plateau decay) during the velopharyngeal closure phase of tubomanometry
  • Ability to maintain velopharyngeal closure after 2 months of rest compared with baseline
    • Time Frame: Baseline and 4 months
    • Amplitude of pressure change (plateau decay) during the velopharyngeal closure phase of tubomanometry
  • Overall success in velopharyngeal closure after 2 months of exercise compared with baseline
    • Time Frame: Baseline and 2 months
    • Area under the curve (pressure tracing during swallow) from tubomanometry
  • Overall success in velopharyngeal closure following 2 months of rest compared with baseline
    • Time Frame: Baseline and 4 months
    • Area under the curve (pressure tracing during swallow) from tubomanometry

Participating in This Clinical Trial

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
  • Tubomanometry test results showing evidence of velopharyngeal dysfunction during swallowing
  • Cleft palate (CP) cohort: non-syndromic; prior Furlow 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
  • Pregnancy
  • Unable or unwilling to perform the tests and exercises outlined in the study

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Noel Jabbour
  • Collaborator
    • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Noel Jabbour, Assistant Professor – University of Pittsburgh
  • Overall Official(s)
    • Noel Jabbour, MD, MS, Principal Investigator, University of Pittsburgh

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