Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cosmetic |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 3/13/2019 |
| Start Date: | April 2019 |
| End Date: | December 2021 |
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 using 1 of 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.
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 of 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.
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. Participants
with active muscular ETD and inadequate soft palate closure will be prescribed soft palate
strengthening exercises for 2 months. The objective of the study is to demonstrate the effect
of exercises on soft palate closure and Eustachian tube function (ETF). This pilot study will
randomly assign 30 children ages 6-17 years with VTs or post-VT extrusion tympanic membrane
(TM) perforations to either the EarPopper or Expiratory Muscle Strength Trainer 150
(EMST150). Fifteen participants will have a history of cleft palate (CP) and 15 no history of
CP. Participants will undergo history, physical examination including an Ear Nose and Throat
(ENT) exam, videoendoscopy and ET function testing including Forced Response Test (FRT),
Inflation- Deflation Test (IDT) and Tubomanometry. They will also undergo pediatric
otolaryngologist and speech pathologist 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 either the EarPopper or EMST150 groups and receive
instruction on the use of their assigned exercise device. This device will be used daily for
2 months. Participants will undergo full evaluations for ET function and velopharyngeal
incompetence after the 2-month treatment and will then discontinue the use of devices for 2
months. Two months following device discontinuation, the same testing will be done. Weekly
phone calls from study staff will encourage use of the devices as prescribed.
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. Participants
with active muscular ETD and inadequate soft palate closure will be prescribed soft palate
strengthening exercises for 2 months. The objective of the study is to demonstrate the effect
of exercises on soft palate closure and Eustachian tube function (ETF). This pilot study will
randomly assign 30 children ages 6-17 years with VTs or post-VT extrusion tympanic membrane
(TM) perforations to either the EarPopper or Expiratory Muscle Strength Trainer 150
(EMST150). Fifteen participants will have a history of cleft palate (CP) and 15 no history of
CP. Participants will undergo history, physical examination including an Ear Nose and Throat
(ENT) exam, videoendoscopy and ET function testing including Forced Response Test (FRT),
Inflation- Deflation Test (IDT) and Tubomanometry. They will also undergo pediatric
otolaryngologist and speech pathologist 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 either the EarPopper or EMST150 groups and receive
instruction on the use of their assigned exercise device. This device will be used daily for
2 months. Participants will undergo full evaluations for ET function and velopharyngeal
incompetence after the 2-month treatment and will then discontinue the use of devices for 2
months. Two months following device discontinuation, the same testing will be done. Weekly
phone calls from study staff will encourage use of the devices as prescribed.
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
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