Clinical trial NCT03868891: Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
Official title: 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: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cleft Palate
Tube Disorders Eustachian
Velopharyngeal Incompetence Due to Cleft Palate
Velopharyngeal Insufficiency
Keywords: Otitis media
Eustachian tube
Eustachian tube dysfunction
Eustachian tube function testing
Middle ear ventilation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2019-03-11
Enrollment: 11
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: experimental, open label
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eustachian Tube Function at 2 Months
timeFrame: 2 months
Secondary outcomes:
measure: Eustachian Tube Function at 4 Months
timeFrame: 4 months
Other outcomes:
measure: Signs of Submucous Cleft Palate Following 2 Months of Exercise Compared With Baseline
timeFrame: Baseline and 2 months
measure: Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Baseline
timeFrame: Baseline and 4 months
measure: Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
timeFrame: 2 months and 4 months
measure: Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Exercise Compared With Baseline
timeFrame: Baseline and 2 months
measure: Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Baseline
timeFrame: Baseline and 4 months
measure: Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
timeFrame: 2 months and 4 months
measure: Eustachian Tube Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
timeFrame: Baseline and 2 months
measure: Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
timeFrame: Baseline and 2 months
measure: Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
timeFrame: Baseline and 4 months
measure: Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
timeFrame: Baseline and 4 months
measure: Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
timeFrame: 2 months and 4 months
measure: Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
timeFrame: 2 months and 4 months
measure: Velopharyngeal Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
timeFrame: Baseline and 2 months
measure: Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
timeFrame: Baseline and 2 months
measure: Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
timeFrame: Baseline and 4 months
measure: Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
timeFrame: Baseline and 4 months
measure: Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
timeFrame: 2 months and 4 months
measure: Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
timeFrame: 2 months and 4 months
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Noel Jabbour, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: