To investigate the natural course of smell alterations in relation to COVID-19. To investigate differences in neuroanatomical structures (olfactory bulb) and neural activity between patients with anosmia and parosmia
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective assessment of parosmia by means of the SSParoT;
Objective olfactory function by means of Sniffin*Sticks;
Objective gustatory function by means of Taste Strips.
With this, we will assess longterm prevalence of parosmia within the cohort, as
well as describe the smell and taste ability of patients. Mean and median time
interval to clinical improvement (recovery) will be reported as measure of
duration of parosmia.
For the neuroimaging part: differences in olfactory bulb volume, differences in
volume of olfactory-related brain regions, and differences in activation of
brain regions upon odor stimuli between patients with smell loss (i.e. anosmia
and hyposmia) and parosmia will be analyzed.
Secondary outcome
To assess the longterm prevalence of anosmia, hyposmia, and taste loss.
To measure smell and taste function subjectively longitudinally in a cohort of
Covid-19 patients with self-reported smell loss.
To assess the impact of smell/taste changes on eating behavior and quality of
life.
To assess changes over time in olfactory bulb volume, volume of
olfactory-related brain regions over time, and functional responses in a subset
of Covid-19 patients
Background summary
Smell loss is one of the most frequent symptoms -and predictor- of COVID-19,
can be long-lasting and have devastating impact on eating behavior and daily
life. In particular, patients often report that after a period of smell loss
(anosmia), they develop a distorted sense of smell (parosmia). Yet the course
and frequency of this conversion is unknown, and treatment or advice and
prognosis is currently still lacking.
Study objective
To investigate the natural course of smell alterations in relation to COVID-19.
To investigate differences in neuroanatomical structures (olfactory bulb) and
neural activity between patients with anosmia and parosmia
Study design
A prospective cohort study to assess smell alterations in COVID-19 patients.
Every 3 months, patients will be objectively tested on their smell and taste
ability, including parosmia. In addition, patients will fill out online
questionnaires related to their smell and taste ability, trigeminal sensations,
eating behavior, quality of life, and perform an at-home test every month. A
subset of patients will be included in an observational case-control study with
one time follow-up, where we will perform neuroimaging. Those patients will
participate in one or two scanning sessions (upon inclusion, and potential
followup after 6 months), including structural and functional MRI in which
patients are exposed to different olfactory stimuli.
Study burden and risks
The study involves a maximum of 20 test sessions. For 13 test sessions
(T0-T12), patients can perform tests and questionnaires independently at their
own homes (60min). For 5 test sessions (T0, T3, T6, T9, T12), a researcher will
additionally visit the patients at their own home to perform objective smell
and taste testing (max 2 hrs). For the 2 scanning sessions, patients will need
to come to the hospital (1hr). There is no therapeutic benefit for the patients
by participating in this study. There are no known risks associated with the
used odors, tastants, and tests. MRI is an eminently safe technique; there are
no risks that have been associated with the acquisition of MRI data per se. The
only burden is the time-investment for the patient.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
patients (18-60 years) with persistent (> 1month) self-reported smell loss
within three months after COVID-diagnosis.
For the neuroimaging substudy: patients (18-60 years) with persistent (>
1month) self-reported smell loss after COVID-diagnosis.
Exclusion criteria
any pre-existing olfactory or gustatory disorders ( i.e. more than 2 weeks
prior to the covid-infection)
for the neuroimaging subpart:
pregnant, or intending to become pregnant during the course of the study
Having a contra-indication to MRI scanning
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77954.091.21 |
| OMON | NL-OMON28538 |