Otitis Media With Effusion Clinical Trial
Official title:
The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
| NCT number | NCT00547326 |
| Other study ID # | 2007/397 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated |
| Verified date | July 2021 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Children with otitis media with effusion will be treated with osteopatic cranial techniques or with a placebo treatment. Before and after the treatment audiometric and tympanometric measures will take place. This procedure will be repeated 3 times, once a week and every session will last for 30-45 minutes. The fourth week, only audiometry and tympanomtry will be done.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 7 Years |
| Eligibility | Inclusion Criteria: - children between 3 and 7 years old - Bilateral otitis media with effusion - Tympanogram type B Exclusion Criteria: - ventilation tubes - Damage of the tympanic membrane - Operation of the tympanic membrane - Other illness e.g. Down, craniofacial abnormalities,… |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Audiometric and tympanometric results | directly after every session of treatment (3 times, once a week) | ||
| Secondary | Audiometric and tympanometric results | one week after the last treatment session. |
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