An interventional study of ENT exam and Olfactometry in Olfaction Disorders and COVID-19, sponsored by Hopital Foch. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by Hopital Foch · Not applicable, Interventional, and Diagnostic
Olfactory and gustatory disorders are prevalent symptoms in European COVID-19 patients. This study aimed to detect these disturbances among positive COVID-19 patients (symptom not initially highlighted by the patient and not sought by caregivers) in order to allow early management of olfactory and gustatory dysfunction.
Several medical teams have recently shown that disturbances of smell and taste are common and can be a precursor and even an isolated sign of COVID-19 involvement. Preliminary results suggest the presence of clinical MRI abnormalities, particularly in the olfactory bulbs in anosmic patients with COVID-19.
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.
70 studies on the registry are indexed under Olfaction Disorders; 18 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 49 interventional studies indexed under Olfaction Disorders.
Browse Olfaction Disorders studies →Hopital Foch is the lead sponsor of 215 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo ENT exams, olfactometry and MRI.
Diagnostic Test: ENT exam · Diagnostic Test: Olfactometry · Diagnostic Test: Brain MRI
ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.
Olfactometry test using odorous pens (Sniffin's stick test).
Brain MRI focused on the olfactory bulbs (3 teslas).
To compare the qualitative and quantitative morphological abnormalities of the olfactory bulb detected by MRI on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner.
Time frame: initial examination
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Sniffin' test score (T threshold score, D discrimination score, I identification score).
Time frame: initial examination
Longitudinal evaluation of qualitative and quantitative abnormalities of olfactory bulbs on MRI in in COVID-19 anosmic patient at initial examination, between 6 weeks and 2 months and between 6 and 9 months.
Intensity ratio calculated between average signals of the olfactory bulb and the frontal white matter on a 3-Tesla MRI scanner at initial examination, between 6 weeks and 2 months and between 6 and 9 months.
Time frame: initial examination, 6 week to 2 months, 6 to 9 months
To compare the result of the olfactometry (Sniffin' test) on initial examination in COVID-19 anosmic versus COVID-19 normosmic patients.
Sniffin' test score (T threshold score, D discrimination score, I identification score).
Time frame: initial examination, 6 week to 2 months, 6 to 9 months
Plan to share: No
Ran from Sep 2020 to primary completion in Sep 2021, 12 months.
Of 20 interventional studies with no phase under Olfaction Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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