Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT01925495
Eligibility Criteria:
Inclusion Criteria:
* Otherwise healthy adults aged 18 to 50 years, inclusive
* No history of significant ME disease
* No history of past ME surgeries
* Able to comprehend study risks and provide written Informed Consent
Exclusion Criteria:
* Have any chronic health problem
* Have ME fluid or otitis media (OM)at the time of presentation
* Have drainage through the tympanostomy tube at the time of testing
* Taking any prescription drug with the exception of those for birth control that would interfere with study per study MD
* Have a known or suspected allergy/adverse reaction to any of the study drugs use to prepare the tympanic membrane for ventilation tube insertion or the nasopharynx for EMG needle insertion
* Have a hearing threshold \>15 dB or a \>10 dB air-bone gap at any of the speech frequencies
* Pregnant or nursing
* Temporary exclusion: expected need for seasonal allergy med during study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01925495
Study Brief:
Protocol Section:
NCT01925495