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Characteristics of the Anosmic Olfactory Mucosa

Recruiting
25 - 35 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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.

Study details

Anosmia, COVID-19, Head Injury

NCT05562050

Nicolai Nielsen

1 May 2024

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