Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Noel Jabbour, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE March 11, 2019
Last Update Posted Date December 14, 2020
Actual Study Start Date  ICMJE August 16, 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2020)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: March 6, 2019)
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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 ]
    Maximum and 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
 
Descriptive Information
Brief Title  ICMJE Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Cleft Palate
  • Tube Disorders Eustachian
  • Velopharyngeal Incompetence Due to Cleft Palate
  • Velopharyngeal Insufficiency
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: EMST150
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
Intervention: Device: EMST150
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 6, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03868891
Other Study ID Numbers  ICMJE PRO18110061
5R21DC017553-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party Noel Jabbour, University of Pittsburgh
Study Sponsor  ICMJE Noel Jabbour
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Noel Jabbour, MD, MS University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP