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Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
NA trial testing EMST150 in Cleft Palate in 11 participants. Terminated before completion.
| Lead sponsor | Noel Jabbour |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 16 August 2019 |
| Primary completion | 6 April 2022 |
| Estimated completion | 31 May 2022 |
| Sites | 1 location across United States |
Noel Jabbour
Adults 6 to 17, any sex, with Cleft Palate or Tube Disorders Eustachian. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months
| Group | Value | 95% CI |
|---|---|---|
| EMST150 | 12.0 | 10.4 – 65.8 |
| EMST150 + Eustachi | 83.6 | 77.5 – 89.7 |
| Group | Value | 95% CI |
|---|---|---|
| EMST150 | 8.5 | 4.7 – 10.4 |
| EMST150 + Eustachi | 44.0 | 33.2 – 54.8 |
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months
| Group | Value | 95% CI |
|---|---|---|
| EMST150 | 64.1 | 23.0 – 87.2 |
| Group | Value | 95% CI |
|---|---|---|
| EMST150 | 6.5 | 6.0 – 9.9 |
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months
| Group | Value | 95% CI |
|---|---|---|
| EMST150 | 64.1 | 23.0 – 87.2 |
| Group | Value | 95% CI |
|---|---|---|
| EMST150 | 6.5 | 6.0 – 9.9 |
Time frame: 8 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | EMST150 | EMST150 + Eustachi |
|---|---|---|---|
| Upper Respiratory Infection | General disorders | — | — |
| Epistaxis | General disorders | — | — |
| Otalgia | Ear and labyrinth disorders | — | — |
| Gastrointestinal Discomfort or Infection | General disorders | — | — |
| Patulous Eustachian Tube | Ear and labyrinth disorders | — | — |
| Acute Otitis Media | Ear and labyrinth disorders | — | — |
| COVID-19 | General disorders | — | — |
| Allergic Rhinitis Symptoms | General disorders | — | — |
| Bloody Otorrhea | Ear and labyrinth disorders | — | — |
Data from ClinicalTrials.gov NCT03868891 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing