Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients
NCT ID: NCT04526054
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
13 participants
INTERVENTIONAL
2020-09-03
2021-09-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Diagnostic Value of Patient - Reported and Clinically Verified Olfactory Disorders (COVID-19)
NCT04407494
Risk of Posterior Staphyloma in Highly Myopic Europeans : From Epidemiology to Anatomy.
NCT06949579
Distinction of Cone Outer Segment Tips by Spectral-Domain Optical Coherence Tomography in Normal Eyes
NCT01316003
Oculomotor Testing in the Differential Diagnosis of Dementia
NCT01577394
Design of an Augmented Reality System by Integration of CT Scan or MRI Data With Endoscopic Images for Video-assisted Endonasal Endoscopic Surgery
NCT04968561
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Anosmia and taste disturbance are early warning signs that could be important in improving the detection and diagnosis of COVID-19, and also in monitoring disease. In addition, disturbances in smell and taste could be an aid in establishing the prognosis of the clinical course of the viral disease. The question of olfactory recovery is also fundamental. To date, we do not know the possibilities of recovery from COVID-19 post viral anosmia. ENT exams, olfactometry and MRI are proposed to study these phenomena.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
anosmic or normosmic COVID-19 patients
Patients will undergo ENT exams, olfactometry and MRI.
ENT exam
ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.
Olfactometry
Olfactometry test using odorous pens (Sniffin's stick test).
Brain MRI
Brain MRI focused on the olfactory bulbs (3 teslas).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ENT exam
ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.
Olfactometry
Olfactometry test using odorous pens (Sniffin's stick test).
Brain MRI
Brain MRI focused on the olfactory bulbs (3 teslas).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient with or without a sense of smell diagnosed with a positive COVID-19 PCR test by nasopharyngeal swab in one of the investigation centers
* Patient who has already undergone cerebral MRI and olfactometry, as part of their routine care, within 3 days of being diagnosed with COVID-19+ or who agrees to undergo cerebral MRI and olfactometry within 3 days of being diagnosed with COVID-19+.
* Patient who signed a consent form
* Patient being affiliated to a Health Insurance plan
Exclusion Criteria
* History of major craniofacial trauma that led to loss of smell
* History of chronic sense of smell
* Diagnosis of Parkinson's disease or Alzheimer's disease
* Refusal to perform the 3 MRIs
* Refusal to participate in the study
* Pregnant, parturient or lactating woman
* Patient with contraindications to performing MRI
* Patient not speaking or understanding French
* Patient deprived of liberty or under guardianship
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hôpital Raymond Poincaré
OTHER
Hopital Foch
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephane Hans, Pr
Role: STUDY_DIRECTOR
Hopital Foch, Suresnes
Robert-Yves Carlier, Pr
Role: PRINCIPAL_INVESTIGATOR
Hopital Raymond Poincare, Garches
Jerome Lechien, Dr
Role: PRINCIPAL_INVESTIGATOR
Hopital Foch, Suresnes
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital Raymond Poincare
Garches, , France
Hopital Foch
Suresnes, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020_0057
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.