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Characteristics of the Anosmic Olfactory Mucosa

Characteristics of the Anosmic Olfactory Mucosa

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05562050
Enrollment
18
Registered
2022-09-30
Start date
2023-11-01
Completion date
2024-10-30
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anosmia, COVID-19, Head Injury

Brief summary

The present study aims to describe the structural tissue and cell characteristics of the olfactory mucosa in patients with persistent anosmia (≥2 years) due to COVID-19 or head-trauma, in comparison to healthy individuals with intact olfactory function. In order to avoid possible age-related degenerative changes in the neuro-epithelium, both patients and controls are between 25 and 35 years of age.

Interventions

None listed

Sponsors

Nicolai Nielsen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
25 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Histological evaluation2023-2024density
Immunohistochemical evaluation2023-2024density

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026