Characteristics of the Anosmic Olfactory Mucosa

COVID-19 Clinical Trial

Official title:

Characteristics of the Anosmic Olfactory Mucosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562050
• Other study ID #: 1-10-72-106-22
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: Regional Hospital West Jutland
• Contact: Nicolai Nielsen, MD
• Phone: +4523411737
• Email: n-nielsen[@]live.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: October 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 35 Years

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.

Related Conditions & MeSH terms

• Anosmia
• COVID-19
• Craniocerebral Trauma
• Head Injury

Locations

Country	Name	City	State
Denmark	ENT department	Herning

Sponsors (1)

Lead Sponsor	Collaborator
Nicolai Nielsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological evaluation	density	2023-2024
Primary	Immunohistochemical evaluation	density	2023-2024