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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT01976559
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of suspected hydrocephalus or shunt malfunction
* CSF infusion testing has been recommended on the basis of standard clinical criteria
* Capable of providing valid signed informed consent
* Normal middle-ear function as determined by tympanometry
* DPOAE meet criteria that are required for the research
* Acoustic stapedial reflex meets criteria that are required for the research
* Subject is willing and able to participate in the study
Exclusion Criteria:
* Subject is pregnant
* Subject lacks decision-making capacity
* Subject is unwilling to participate in the study
* Prior middle-ear disease or surgery, with the exception of tympanostomy tubes that have been removed and are healed
* Participating in the study would significantly delay or interfere with the subject's healthcare
* Subject has excess ear wax that cannot be removed safely and could potentially be pushed onto the ear drum by insertion of the ear plugs needed for the testing
* The TMD or DPOAE do not respond to a change in posture from lying flat to standing up, which means that the anatomic connection between the inner ear and the CSF is absent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01976559
Study Brief:
Protocol Section:
NCT01976559