Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04492904 |
| Other study ID # |
2020/00810 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 17, 2020 |
| Est. completion date |
June 15, 2021 |
Study information
| Verified date |
December 2021 |
| Source |
Clinical Nutrition Research Centre, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The study aims to longitudinally track the onset, severity and recovery of changes in
chemosensory acuity (smell and/or taste loss) among those suspected of COVID-19 infection.
Using standardised questionnaire and testing approaches, the investigators aim to objectively
characterise and measure temporal changes in taste and smell to confirm the prevalence of
these symptoms as an early marker of infection. Information on symptoms experience, changes
in appetite and food-related quality of life will be also be assessed via questionnaire.
The results of the study will help individuals who experience a loss of smell and/or taste to
self-isolate and/or self-refer to a medical professional, if an association between smell
and/or taste and COVID-19 infection is found.
Description:
The study will be a retrospective-prospective, longitudinal case-control observational study
using a convenience sample drawn from patients presenting for COVID-19 screening, and will
recruit both males and females above the age of 21 years who consent to provide anonymised
data online on recent changes to their taste and smell. There will be no intervention
(medication or foods) as part of this study. Potential participants will be screened to
ensure they meet the study inclusion and exclusion criteria and all participants will sign an
informed consent.
During their first recruitment session at the hospital/clinic, participants will be required
to complete a series of questionnaires to record recent changes in taste and smell
sensitivity. The series of questionnaires will include: Singapore Smell and Taste
Questionnaire (SSTQ), Sino-nasal Outcome Test-22 (SNOT-22) and optionally, the Global
Consortium of Chemosensory Research Questionnaire (GCCRQ). The purpose of administering the
different questionnaires is to cover wide range of complementary questions that capture
information related to changes in taste and smell function associated with COVID-19
infection. Thereafter participants will be briefed on how to complete the home-use
standardized smell and taste test (Home-use Test). The Home-use Test (HUT) will be completed
daily over a 28 day period at participants place of residence, to enable self-monitoring of
changes to smell and taste abilities. During the HUT, participants will rate their sense of
smell using the two standardised odour pens they are provided on the first day of their
session at the hospital/ clinic. For each pen, participants will be asked to identify the
odour and rate the perceived intensity. This will then be followed a taste test where
participants will take a small quantity of a powder representing each of the four
prototypical basic tastes sweet (sugar), salt (table salt), bitter (coffee powder or tea) and
sour (lime powder), to the tip end of their tongue with a small spoon to taste. Participant
are asked to self-report that they confirm that can identify the taste quality and to rate
the perceived intensity on line scales provided in an online questionnaire. All measures are
self-administered and completed independently by the participant, with responses captured
using unique identifier code for each participant through an online software (CompuSense,
Guelph, Ontario). During the 28-day home use test period, once a week participants will be
asked to complete a 'Follow-up Questionnaire' which will assess how the symptoms experienced
have impacted their enjoyment of food, appetite and food-related quality of life.
