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 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: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • 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 enroll 30 children between ages 6-17 years with VTs or post-VT extrusion tympanic membrane (TM) perforations. All 30 children will have ETD, with active muscular dysfunction. 15 subjects will have a history of cleft palate (CP) and 15 no history of CP. Subjects will undergo history, physical examination including an ENT exam, video-otoscopy and ET function testing which may include 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 receive instruction on the use their EMST150 exercise device. 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/emails/texts from study staff will encourage use of the devices as prescribed.

Interventions

  • 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

  • Experimental: EMST150
    • Subjects with or without cleft palate will use the EMST150 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)
  • Eustachian tube function after 2 months of rest compared with function immediately following 2 months of exercise
    • Time Frame: 2 months and 4 months
    • Percent change in middle ear pressure during the inflation-deflation test (non-intact tympanic membranes) or pressure chamber (intact tympanic membrane)

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 – 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

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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