Characteristics of the Anosmic Olfactory Mucosa

NCT05562050 | Active Not Recruiting DMC

• 1 other identifier: 1-10-72-106-22
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Anosmia; COVID-19; Head Injury

Outcome Measures

Primary Outcomes (2)

• Histological evaluation

  density

  2023-2024

• Immunohistochemical evaluation

  density

  2023-2024

Study Arms (3)

Control

COVID-19 related anosmia

Head-trauma related anosmia

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

recruited from the clinic

You may qualify if:

• 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

You may not qualify if:

• \<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 \[49, 50\]

Sponsors & Collaborators

• Nicolai Nielsen: lead

Study Sites (1)

ENT department

Herning, Denmark

Location

MeSH Terms

Conditions

Anosmia; COVID-19; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Therese Ovesen, DMSc

  Gødstrup Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: September 30, 2022
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 30, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)