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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT05479604
Eligibility Criteria:
Inclusion Criteria:
* Participant must be \> 18 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Facial pain or pressure for \> 3 months of symptom duration.
* Pain/pressure VAS (Visual Analogue Scale) Score of \> 5.
Exclusion Criteria:
* Upper respiratory illness within the last 2 weeks.
* History of severe epistaxis.
* Known pregnancy.
* Allergic sensitivity to silicone or any other component of device.
* Sinonasal surgery in the last 3 months.
* Topical decongestant use in the last week.
* Nasal polyposis, purulence/edema, or other signs of sinusitis on exam.
* Sinusitis on imaging.
* Nasal crusting or ulceration on exam.
* Inability to read or understand English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05479604
Study Brief:
Protocol Section:
NCT05479604