Characteristics of the Anosmic Olfactory Mucosa

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anosmia COVID-19 Coronaviridae Infections Coronavirus Infections Craniocerebral Trauma Head Injury Infections Lung Diseases Nervous System Diseases Neurologic Manifestations Nidovirales Infections Olfaction Disorders Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Signs and Symptoms Trauma, Nervous System Virus Diseases Wounds and Injuries

Age range

25 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ENT department

Herning, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Diagnosed with persistent anosmia for approximately two years concurring with positive SARS-CoV-2 PCR-test between 2019 and 2020.
Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16
Between 25 and 35 years of age.

Study group 2 (Post-trauma anosmia)

Diagnosed with persistent anosmia for approximately two years concurring with head trauma.
Sniffin'sticks test with a threshold-discrimination-identification-score(TDI)≤16
Between 25 and 35 years of age.

Study group 3 (Controls):

Between 25 and 35 years of age.
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)

Anosmia for less than two years or more than two and a half years.
No positive SARS-CoV-2 PCR-test concurring with olfactory dysfunction.
History of olfactory dysfunction before COVID-19 infection.
Study group 2 (Post-trauma anosmia)

Anosmia for less than two years or more than approximately two-three years.
Anosmia without concurring with head trauma
History of prior olfactory dysfunction before head trauma.
Study group 3 (Controls) 1. Known olfactory dysfunction.

Treatment and study plan

Primary outcomes

Histological evaluation

Time frame: 2023-2024

density
Immunohistochemical evaluation

Time frame: 2023-2024

density

Sponsors and collaborators

Lead sponsor

Nicolai Nielsen

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Sep 30, 2022
Registry last updated: Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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