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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cleft Palate; Tube Disorders Eustachian; Velopharyngeal Incompetence Due to Cleft Palate; Velopharyngeal Insufficiency
• Intervention / Treatment: Device: EMST150

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.

The following secondary outcome measures were part of the original study protocol but were eliminated after the start of the COVID-19 pandemic because the tests involved blowing maneuvers and risk of aerosolization. The protocol was modified to only include ETF tests that were necessary to achieve the goals of the study and that were safe for the participants.

'Velopharyngeal pressure after 2 months of exercise compared with baseline' 'Velopharyngeal pressure after 2 months of rest compared with baseline' 'Duration of velopharyngeal closure after 2 months of exercise compared with baseline' 'Duration of velopharyngeal closure after 2 months of rest compared with baseline' 'Ability to maintain velopharyngeal closure after 2 months of exercise compared with baseline' 'Ability to maintain velopharyngeal closure after 2 months of rest compared with baseline' 'Overall success in velopharyngeal closure after 2 months of exercise compared with baseline' 'Overall success in velopharyngeal closure following 2 months of rest compared with baseline'

The following other pre-specified outcome measures were removed for the same reason:

'Velopharyngeal pressure after 2 months of rest compared with pressure immediately following 2 months of exercise' 'Duration of velopharyngeal closure after 2 months of rest compared with pressure immediately following 2 months of exercise' 'Ability to maintain velopharyngeal closure after 2 months of rest compared with ability immediately following 2 months of exercise' 'Overall success in velopharyngeal closure following 2 months of rest compared with success immediately following 2 months of exercise'

'Eustachian tube function after 2 months of rest compared with function immediately following 2 months of exercise' was moved from an other pre-specified outcome measure to a secondary outcome measure due to its similar level of importance to the other secondary outcome measures.

Pressure chamber results were removed from outcome measures because they were unable to be obtained safely during the COVID-19 pandemic.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EMST150; Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.

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.; Other Names: Expiratory Muscle Strength Trainer 150

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eustachian Tube Function at 2 Months	Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eustachian Tube Function at 4 Months	Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs of Submucous Cleft Palate Following 2 Months of Exercise Compared With Baseline	Presence or absence of dimpling anterior to the uvula, soft palate vaulting, midline groove, translucent midline, or visible notch in posterior hard palate observed on palate activation during video-analysis	Baseline and 2 months
Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Baseline	Presence or absence of dimpling anterior to the uvula, soft palate vaulting, midline groove, translucent midline, or visible notch in posterior hard palate observed on palate activation during video-analysis	Baseline and 4 months
Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise	Presence or absence of dimpling anterior to the uvula, soft palate vaulting, midline groove, translucent midline, or visible notch in posterior hard palate observed on palate activation during video-analysis	2 months and 4 months
Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Exercise Compared With Baseline	Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence	Baseline and 2 months
Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Baseline	Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence	Baseline and 4 months
Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise	Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence	2 months and 4 months
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline	Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	Baseline and 2 months
Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline	Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	Baseline and 2 months
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline	Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	Baseline and 4 months
Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Baseline	Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	Baseline and 4 months
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise	Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	2 months and 4 months
Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise	Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	2 months and 4 months
Velopharyngeal Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline	Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	Baseline and 2 months
Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline	Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	Baseline and 2 months
Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline	Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	Baseline and 4 months
Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Baseline	Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	Baseline and 4 months
Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise	Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	2 months and 4 months
Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise	Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa	2 months and 4 months

Collaborators and Investigators

• Sponsor: Noel Jabbour
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Noel Jabbour, MD, MS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2019
• Primary Completion (Actual): April 6, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Otitis media; Eustachian tube; Eustachian tube dysfunction; Eustachian tube function testing; Middle ear ventilation
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Velopharyngeal Insufficiency
• Other Study ID Numbers: PRO18110061; 5R21DC017553-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) may be shared, after de-identification, with researchers who provide a methodologically sound proposal. IPD to be shared will include that necessary to achieve the aims in the approved proposal.
• IPD Sharing Time Frame: Beginning 1 year after publication of summary data. Ending 5 years after publication.
• IPD Sharing Access Criteria: Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No