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

NCT03868891 | Terminated Results DMC FDA Device

• 2 other identifiers: PRO181100615R21DC017553-02
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Eustachian Tube Function at 2 Months

  Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months

  2 months

Secondary Outcomes (1)

• Eustachian Tube Function at 4 Months

  4 months

Other Outcomes (18)

• Signs of Submucous Cleft Palate Following 2 Months of Exercise Compared With Baseline

  Baseline and 2 months

• Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Baseline

  Baseline and 4 months

• Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise

  2 months and 4 months

Study Arms (1)

EMST150

EXPERIMENTAL

Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.

Device: EMST150

Interventions

EMST150 DEVICE

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.

Also known as: Expiratory Muscle Strength Trainer 150

EMST150

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Noel Jabbour: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Cleft Palate; Velopharyngeal Insufficiency; Otitis Media

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Otitis; Ear Diseases

Limitations and Caveats

Enrollment was limited due in part to delays related to COVID-19 restrictions. Another important limiting factor was the studied population itself. Inclusion/exclusion criteria were restrictive, and children who have persistent need for ventilation tubes frequently present with otorrhea or middle ear inflammation or tubes become blocked. These factors affect the feasibility of ETF tests and delayed study visits.

Results Point of Contact

• Title: Dr. Amber Shaffer
• Organization: UPMC Children's Hospital of Pittsburgh

shafferad@upmc.edu

412-692-6874

Study Officials

• Noel Jabbour, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Researchers conducing Eustachian tube function testing and those conducing statistical analysis will be blinded to the visit number.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: experimental, open label

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 11, 2019
• Study Start: August 16, 2019
• Primary Completion: April 6, 2022
• Study Completion: May 31, 2022
• Last Updated: June 23, 2023
• Results First Posted: June 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)