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 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT05562050
Eligibility Criteria:
Inclusion Criteria:
* Legally competent to vouch for their own study participation.
* Informed and written consent for participation in this study.
* Study group 1 (Post-COVID anosmia)
1. Diagnosed with persistent anosmia for approximately two years concurring with positive SARS-CoV-2 PCR-test between 2019 and 2020.
2. Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16
3. Between 25 and 35 years of age.
Study group 2 (Post-trauma anosmia)
1. Diagnosed with persistent anosmia for approximately two years concurring with head trauma.
2. Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16
3. Between 25 and 35 years of age.
Study group 3 (Controls):
1. Between 25 and 35 years of age.
2. Undergoing reposition of a nasal fracture in general anaesthesia
Exclusion Criteria:
* \<25 years of age.
* \>35 years of age.
* Chronic rhinosinusitis with/without polyps.
* Nasal cancer.
* Presence of viral or bacterial rhinosinusitis.
* Uncontrolled allergic rhinosinusitis.
* Coagulation deficiencies, e.g. haemophilia.
* Use of anticoagulants.
* Not able to undergo general anaesthesia.
* Pregnancy.
* Any use of nasal detumescence drugs ≤2 weeks before biopsy.
* Any use of nasal steroids ≤3 months before biopsy.
* Use of nasal inhaled recreational drugs ≤3 month before biopsy.
* Participants not able to communicate in Danish or English.
* Major Depression Inventory (MDI) score ≥27 \[49, 50\]
* Mini Mental State Examination (MMSE) score ≤ 26 \[51\]
* Study group 1 (Post-COVID anosmia)
1. Anosmia for less than two years or more than two and a half years.
2. No positive SARS-CoV-2 PCR-test concurring with olfactory dysfunction.
3. History of olfactory dysfunction before COVID-19 infection.
* Study group 2 (Post-trauma anosmia)
1. Anosmia for less than two years or more than approximately two-three years.
2. Anosmia without concurring with head trauma
3. History of prior olfactory dysfunction before head trauma.
* Study group 3 (Controls) 1. Known olfactory dysfunction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
35 Years
Study:
NCT05562050
Study Brief:
Protocol Section:
NCT05562050