AnosmiaNCT05562050
Characteristics of the Anosmic Olfactory Mucosa
An observational study of Anosmia and COVID-19, run by Nicolai Nielsen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 25 to 35 years
- Conditions the study is for
- Anosmia, COVID-19, Head Injury
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: recruited from the clinic
Who may be able to join
- 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.
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- 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
Who cannot join
- <25 years of age.
- >35 years of age.
- Chronic rhinosinusitis with/without polyps.
- Nasal cancer.
- Presence of viral or bacterial rhinosinusitis.
- Uncontrolled allergic rhinosinusitis.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Anosmia, COVID-19, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described | |
| COVID-19 related anosmia | Not described | |
| Head-trauma related anosmia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological evaluation
density
Measured: 2023-2024
Immunohistochemical evaluation
density
Measured: 2023-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Nov 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicolai Nielsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicolai Nielsen, Regional Hospital West Jutland
- Investigators
- Therese Ovesen, DMSc, Principal investigator, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562050
- Sponsor's protocol ID
- 1-10-72-106-22
- Status last verified
- Aug 2024
- First submitted
- 28 Sep 2022
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of the Anosmic Olfactory Mucosa
- ClinicalTrials.gov ID
- NCT05562050
- Acronym / sponsor ID
- 1-10-72-106-22
- Conditions
- Anosmia, COVID-19, Head Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Nicolai NielsenUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
| COVID-19 related anosmia | – | – |
| Head-trauma related anosmia | – | – |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- recruited from the clinic
Key inclusion criteria (13 listed)
- Legally competent to vouch for their own study participation.
- Informed and written consent for participation in this study.
- Study group 1 (Post-COVID anosmia)
- Study group 2 (Post-trauma anosmia)
- Diagnosed with persistent anosmia for approximately two years concurring with head trauma.
Key exclusion criteria (25 listed)
- <25 years of age.
- >35 years of age.
- Chronic rhinosinusitis with/without polyps.
- Nasal cancer.
- Presence of viral or bacterial rhinosinusitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histological evaluation
Time frame: 2023-2024
density
Immunohistochemical evaluation
Time frame: 2023-2024
density
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese Ovesen, DMSc principal investigator
Gødstrup Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anosmia and COVID-19, run by Nicolai Nielsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological evaluation (time frame: 2023-2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.