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 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT05855369
Eligibility Criteria:
Inclusion Criteria:
* treatment-seeking for COVID-related persistent SL (anosmia, hyposmia, phantosmia or parosmia)
* at least 1-month from SARS-coV-2 PCR-positive and/or rapid home-positive tests
* normal sense of smell prior to COVID
* naïve to both smell training (ST) and trigeminal nerve stimulation (TNS)
* able to comprehend English and provide informed consent
Exclusion Criteria:
* history of head injury (e.g. sport, accident, combat blast)
* sinonasal condition (e.g. upper respiratory infection, rhinosinusitis, polyps)
* neurological disorder (e.g. epilepsy, neurodegenerative disorder, narcolepsy)
* serious mental illness (e.g. schizophrenia, bipolar, or other psychotic disorder)
* suicidal ideation within the last month
* current (≤6 months) heavy cigarette smoker (heavy defined as ≥ 10 pack-years)
* oral/nasal steroids or other intranasal medications within the last month
* immunomodulatory medications
* pregnant or trying to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05855369
Study Brief:
Protocol Section:
NCT05855369