Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
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ClinicalTrials.gov Identifier: NCT03868891 |
Recruitment Status :
Suspended
(All study procedures have been suspended since March 20, 2020 due to Coronavirus Disease 2019.)
First Posted : March 11, 2019
Last Update Posted : December 14, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cleft Palate Tube Disorders Eustachian Velopharyngeal Incompetence Due to Cleft Palate Velopharyngeal Insufficiency | Device: EMST150 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention 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. |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | August 16, 2019 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
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Experimental: EMST150
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
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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 Name: Expiratory Muscle Strength Trainer 150 |
- 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)
- 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)
- Signs of submucous cleft palate following 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]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
- Signs of submucous cleft palate following 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]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
- Signs of submucous cleft palate following 2 months of rest compared with immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]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
- Perceptual speech symptoms of velopharyngeal dysfunction following 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
- Perceptual speech symptoms of velopharyngeal dysfunction following 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
- Perceptual speech symptoms of velopharyngeal dysfunction following 2 months of rest compared with immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
- Eustachian tube function observed during maneuvers following 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Residual middle ear pressure observed during maneuvers following 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Eustachian tube function observed during maneuvers following 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Residual middle ear pressure observed during maneuvers following 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Eustachian tube function observed during maneuvers following 2 months of rest compared with immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Residual middle ear pressure observed during maneuvers following 2 months of rest compared with immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Velopharyngeal function observed during maneuvers following 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Residual nasopharyngeal pressures observed during maneuvers following 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Velopharyngeal function observed during maneuvers following 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Residual nasopharyngeal pressures observed during maneuvers following 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Velopharyngeal function observed during maneuvers following 2 months of rest compared with immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
- Residual nasopharyngeal pressures observed during maneuvers following 2 months of rest compared with immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa

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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868891
United States, Pennsylvania | |
UPMC Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15224 |
Principal Investigator: | Noel Jabbour, MD, MS | University of Pittsburgh |
Responsible Party: | Noel Jabbour, Assistant Professor, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT03868891 |
Other Study ID Numbers: |
PRO18110061 5R21DC017553-02 ( U.S. NIH Grant/Contract ) |
First Posted: | March 11, 2019 Key Record Dates |
Last Update Posted: | December 14, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Beginning 1 year after publication of summary data. Ending 5 years after publication. |
Access Criteria: | Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement. |
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 |
Otitis media Eustachian tube Eustachian tube dysfunction Eustachian tube function testing Middle ear ventilation |
Cleft Palate Velopharyngeal Insufficiency Jaw Abnormalities Jaw Diseases Musculoskeletal Diseases Maxillofacial Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities |
Stomatognathic Diseases Mouth Abnormalities Mouth Diseases Stomatognathic System Abnormalities Congenital Abnormalities Pharyngeal Diseases Otorhinolaryngologic Diseases |