Trials / Completed
CompletedNCT04840966
A Simplified Test to Assess Flavor in COVID-19 Patients
Simplified Flavor Test for Self-administation in COVID-19 Positive Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 111 (actual)
- Sponsor
- Federico II University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The Flavor test has been developed and validated by our group to assess retro-nasal olfactory performances. The original flavor test has been simplified, with the great advantage to be self-administrable for COVID-19 patients in isolation, without any risk to health professionals.
Detailed description
Smell and taste dysfunctions (STDs) are symptoms associated with COVID-19 syndrome, even if their incidence is still uncertain and variable. In this study, the effects of SARS-CoV-2 infection on chemosensory function have been investigated using both a self-reporting questionnaire on smell and flavor perception, and a simplified flavor test. A total of 111 subjects (19 hospitalized \[HOS\] and 37 home-isolated \[HI\] COVID-19 patients, and 55 healthy controls \[CTRL\]) were enrolled in the study. The flavor test used consists in the self-administration of four solution with a pure olfactory stimulus (coffee), a mixed olfactory-trigeminal stimulus (peppermint), and a complex chemical mixture (banana). After SARS-CoV-2 infection, HOS and HI patients reported similar frequency of STDs, with a significant reduction of both smell and flavor self-estimated perception. The aromas of the Flavor test were recognized by HI and HOS COVID-19 patients similarly to CTRL, however the intensity of the perceived aromas was significantly lower in patients compared to controls. This suggests that a chemosensory impairment is present after SARS-CoV-2 infection, and the modified "flavor test" could be a novel self-administering objective screening test to assess STDs in COVID-19 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Flavor test | A simplified self-administrable flavor test has been proposted to all the enrolled subjects |
| OTHER | Self-assesment questionnaire | Questionnaire to score subjective chemosensory function (smell and flavor) before and after COVID-19 using a 0-10 scale with 0 corresponding to "no smell/flavor perception" and 10 corresponding to "excellent smell/flavor perception". |
Timeline
- Start date
- 2020-05-05
- Primary completion
- 2021-01-15
- Completion
- 2021-01-15
- First posted
- 2021-04-12
- Last updated
- 2021-04-15
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04840966. Inclusion in this directory is not an endorsement.