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Characteristics of the Anosmic Post-COVID-19 Olfactory Mucosa

Sponsor
Nicolai Nielsen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05562050
Collaborator
(none)
18
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    18 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Characteristics of the Anosmic Post-COVID-19 Olfactory Mucosa
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Control
    COVID-19 related anosmia
    Head-trauma related anosmia

    Outcome Measures

    Primary Outcome Measures

    1. Histological evaluation [2023]

    2. Immunohistochemical evaluation [2023]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nicolai Nielsen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicolai Nielsen, Medical doctor, Regional Hospital West Jutland
    ClinicalTrials.gov Identifier:
    NCT05562050
    Other Study ID Numbers:
    • 1-10-72-106-22
    First Posted:
    Sep 30, 2022
    Last Update Posted:
    Sep 30, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Craniocerebral Trauma
    Anosmia

    Study Results

    No Results Posted as of Sep 30, 2022