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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT03132961
Eligibility Criteria:
Inclusion Criteria:
1. Age of 18 to 60 years
2. Absence of otologic symptoms based on screening questionnaire
3. Normal otoscopic examination
4. Audiometric thresholds less than 25 dB at 250, 500, 750, 1000 Hz.
Exclusion Criteria:
1. Age less than 18 or greater than 60 years. Age greater than 60 is considered an exclusion criterion as prior studies have demonstrated elevated VEMP thresholds attributed to age
2. Presence of any positive symptom on the questionnaire
3. Thresholds greater than 25 dB at the tested frequencies
4. Abnormal otoscopic examination (e.g., ear canal occlusion, tympanic membrane perforation, tympanic membrane retraction)
5. History of prior ear surgery.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03132961
Study Brief:
Protocol Section:
NCT03132961