Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
Primary Purpose
Cleft Palate, Tube Disorders Eustachian, Velopharyngeal Incompetence Due to Cleft Palate
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMST150
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Palate focused on measuring Otitis media, Eustachian tube, Eustachian tube dysfunction, Eustachian tube function testing, Middle ear ventilation
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
Sites / Locations
- UPMC Children's Hospital of Pittsburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EMST150
Arm Description
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
Outcomes
Primary Outcome Measures
Eustachian Tube Function at 2 Months
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months
Secondary Outcome Measures
Eustachian Tube Function at 4 Months
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months
Full Information
NCT ID
NCT03868891
First Posted
February 14, 2019
Last Updated
May 30, 2023
Sponsor
Noel Jabbour
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03868891
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
End of funding
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Noel Jabbour
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
experimental, open label
Masking
None (Open Label)
Masking Description
Researchers conducing Eustachian tube function testing and those conducing statistical analysis will be blinded to the visit number.
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMST150
Arm Type
Experimental
Arm Description
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
Intervention Type
Device
Intervention Name(s)
EMST150
Other Intervention Name(s)
Expiratory Muscle Strength Trainer 150
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eustachian Tube Function at 2 Months
Description
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Eustachian Tube Function at 4 Months
Description
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Signs of Submucous Cleft Palate Following 2 Months of Exercise Compared With Baseline
Description
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
Time Frame
Baseline and 2 months
Title
Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Baseline
Description
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
Time Frame
Baseline and 4 months
Title
Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Description
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
Time Frame
2 months and 4 months
Title
Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Exercise Compared With Baseline
Description
Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
Time Frame
Baseline and 2 months
Title
Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Baseline
Description
Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
Time Frame
Baseline and 4 months
Title
Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Description
Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
Time Frame
2 months and 4 months
Title
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
Description
Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
Baseline and 2 months
Title
Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
Description
Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
Baseline and 2 months
Title
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
Description
Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
Baseline and 4 months
Title
Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
Description
Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
Baseline and 4 months
Title
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Description
Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
2 months and 4 months
Title
Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Description
Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
2 months and 4 months
Title
Velopharyngeal Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
Description
Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
Baseline and 2 months
Title
Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
Description
Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
Baseline and 2 months
Title
Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
Description
Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
Baseline and 4 months
Title
Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
Description
Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
Baseline and 4 months
Title
Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Description
Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
2 months and 4 months
Title
Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Description
Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time Frame
2 months and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel Jabbour, MD, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
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