NCT03868891|TerminatedResultsDMCFDA Device
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End of funding
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
Sponsor study identifier
Secondary identifiers
interventional
11
1 country
1
Study Start
August 16, 2019
Actual (reported)Primary Completion
April 6, 2022
Actual (reported)Study Completion
May 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 14, 2019
Actual (reported)March 11, 2019
Actual (reported)August 16, 2019
Actual (reported)April 6, 2022
Actual (reported)May 31, 2022
Actual (reported)June 23, 2023
Actual (reported)Eustachian Tube Function at 2 Months
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months
2 months
Eustachian Tube Function at 4 Months
4 months
Signs of Submucous Cleft Palate Following 2 Months of Exercise Compared With Baseline
Baseline and 2 months
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
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.
Noel Jabbour, MD, MS
University of Pittsburgh
11 participants (actual enrollment reported by the registry).
First Submitted
February 14, 2019
First Posted
March 11, 2019
Study Start
August 16, 2019
Effect of Cleft Palate Repair Using Alveolar Extension Technique on Eruption and Growth
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
Contact the study team to confirm eligibility.
Primary Completion
April 6, 2022
Actual (reported)Study Completion
May 31, 2022
Actual (reported)Last Updated
June 23, 2023
Results First Posted
June 23, 2023
Record last verified: 2023-05
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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