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ID
Source
Brief title
Health condition
COVID-19
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. For the neuroimaging part: activation of brain regions in response to odor administration; activation of functional connectivity networks in the brain in response to odor administration; volume of the olfactory bulbs; total brain volume and volume of olfactory-related brain regions
Secondary outcome
Self-reported smell, taste, parosmia and trigeminal sensations; scores on home-use-test (https://riech-check.de/); eating behavior, as measured by the Appetite, Hunger and Sensory Perception questionnaire and VAS ratings on food enjoyment and appetite; quality of life, as measured by the Questionnaire of Olfactory Disorders
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. Therefore, we will investigate both the natural course of smell alterations in relation to Covid-19 and differences in neural activity between anosmia and parosmia. This will be done in a prospective cohort study. A subset of patients will be included in an observational case-control study with one time follow-up, where we will perform neuroimaging. 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. For the neuroimaging part, patients will participate in two scanning sessions (upon inclusion, and follow-up after 6 months), including structural and functional MRI in which patients are exposed to different olfactory stimuli.
Study objective
We expect that smell and taste function will be decreased shortly after infection, but that smell and taste function will recover over time. Part of the patients will develop parosmia. Smell loss due to a Covid-19 infection will affect structure and function of olfaction-related areas in the brain.
Study design
The study involves a maximum of 20 test sessions (T0 – T12, plus the additional objective tests at T0, T3, T6, T9 and T12, plus 2 neuroimaging sessions). Test sessions will take place each month.
Intervention
N/A
Inclusion criteria
Aged between 18-60 years, as olfactory function typically declines after the age of 60 years; recent Covid-19 infection (< 3 months), confirmed with a positive PCR-test, performed at a hospital or by the GGD; persistent self-reported smell loss (> 1 month); willing to comply with the study procedures; Dutch speaking; having given informed consent
Exclusion criteria
Having any pre-existing olfactory or gustatory disorders (i.e. more than 2 weeks prior to the Covid-infection)
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9780 |
| CCMO | NL77954.091.21 |
| OMON | NL-OMON54465 |