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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 : Not yet recruiting
First Posted : March 11, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Noel Jabbour, University of Pittsburgh

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 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.

Condition or disease Intervention/treatment Phase
Cleft Palate Tube Disorders Eustachian Velopharyngeal Incompetence Due to Cleft Palate Velopharyngeal Insufficiency Device: EarPopper Device: EMST150 Not Applicable

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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: experimental, randomized, open label, parallel arm
Masking: Single (Outcomes Assessor)
Masking Description: Individuals assigning participants to treatment arms, researchers conducing Eustachian tube function testing, and those conducing statistical analysis will be blinded to the treatment arm.
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Active Comparator: EarPopper
Subjects with or without cleft palate will use the EarPopper 2 times a day for 8 weeks.
Device: EarPopper
This device has a handle attached to a nose probe that delivers a constant airflow into the nose. The EarPopper is turned on and while one nostril is pinched with one finger, the nose probe is sealed in the other nostril. Participants will swallow and will complete an exercise diary recording whether a popping or pressure change was felt in the left, right or both ears. When an increase in ear pressure is felt, participants will swallow 5 times. This will be marked in the exercise diary. In addition, participants will slowly blow air out through their mouths for about 5-10 seconds while the EarPopper is on and placed into the nostril. The amount of time participants are able to blow will also be recorded in the diary.

Active Comparator: EMST150
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
Device: EMST150
This device consists of a handheld plastic tube with a mouthpiece on one end and an adjustable valve on the other end. Each participant 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, participants 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. Participants will adjust the resistance of the device each week and enter device settings and document exercise sets performed in an exercise diary.
Other Name: Expiratory Muscle Strength Trainer 150




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. Velopharyngeal pressure after 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]
    Maximum pressure achieved during tubomanometry with respect to the delivered pressure (% max achieved)

  3. Velopharyngeal pressure after 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]
    Maximum pressure achieved during tubomanometry with respect to the delivered pressure (% max achieved)

  4. Duration of velopharyngeal closure after 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]
    Duration of plateau (velopharyngeal closure phase) during tubomanometry

  5. Duration of velopharyngeal closure after 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]
    Duration of plateau (velopharyngeal closure phase) during tubomanometry

  6. Ability to maintain velopharyngeal closure after 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]
    Amplitude of pressure change (plateau decay) during the velopharyngeal closure phase of tubomanometry

  7. Ability to maintain velopharyngeal closure after 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]
    Amplitude of pressure change (plateau decay) during the velopharyngeal closure phase of tubomanometry

  8. Overall success in velopharyngeal closure after 2 months of exercise compared with baseline [ Time Frame: Baseline and 2 months ]
    Area under the curve (pressure tracing during swallow) from tubomanometry

  9. Overall success in velopharyngeal closure following 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]
    Area under the curve (pressure tracing during swallow) from tubomanometry


Other Outcome Measures:
  1. 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)

  2. Velopharyngeal pressure after 2 months of rest compared with pressure immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]
    Maximum pressure achieved during tubomanometry with respect to the delivered pressure (% max achieved)

  3. Duration of velopharyngeal closure after 2 months of rest compared with pressure immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]
    Duration of plateau (velopharyngeal closure phase) during tubomanometry

  4. Ability to maintain velopharyngeal closure after 2 months of rest compared with ability immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]
    Amplitude of pressure change (plateau decay) during the velopharyngeal closure phase of tubomanometry

  5. Overall success in velopharyngeal closure following 2 months of rest compared with success immediately following 2 months of exercise [ Time Frame: 2 months and 4 months ]
    Area under the curve (pressure tracing during swallow) from tubomanometry

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Residual middle ear pressure observed during maneuvers following 2 months of rest compared with baseline [ Time Frame: Baseline and 4 months ]
    Maximum and residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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
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
  • 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

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
UPMC Children's Hospital of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Amber D Shaffer, PhD    412-692-6874    shafferad@upmc.edu   
Contact: Juliane Banks, BS    412-692-3595    Juliane.Banks@chp.edu   
Sponsors and Collaborators
Noel Jabbour
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Noel Jabbour, MD, MS University of Pittsburgh

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Responsible Party: Noel Jabbour, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03868891     History of Changes
Other Study ID Numbers: PRO18110061
1R21DC017553-01 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Noel Jabbour, University of Pittsburgh:
Otitis media
Eustachian tube
Eustachian tube dysfunction
Eustachian tube function testing
Middle ear ventilation

Additional relevant MeSH terms:
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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