<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04492904</url>
  </required_header>
  <id_info>
    <org_study_id>2020/00810</org_study_id>
    <nct_id>NCT04492904</nct_id>
  </id_info>
  <brief_title>Singapore COVID-19 Chemosensory Tracking (SCCT) Study</brief_title>
  <official_title>Singapore COVID-19 Chemosensory Tracking (SCCT) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Nutrition Research Centre, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinical Nutrition Research Centre, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to longitudinally track the onset, severity and recovery of changes in&#xD;
      chemosensory acuity (smell and/or taste loss) among those suspected of COVID-19 infection.&#xD;
      Using standardised questionnaire and testing approaches, the investigators aim to objectively&#xD;
      characterise and measure temporal changes in taste and smell to confirm the prevalence of&#xD;
      these symptoms as an early marker of infection. Information on symptoms experience, changes&#xD;
      in appetite and food-related quality of life will be also be assessed via questionnaire.&#xD;
&#xD;
      The results of the study will help individuals who experience a loss of smell and/or taste to&#xD;
      self-isolate and/or self-refer to a medical professional, if an association between smell&#xD;
      and/or taste and COVID-19 infection is found.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be a retrospective-prospective, longitudinal case-control observational study&#xD;
      using a convenience sample drawn from patients presenting for COVID-19 screening, and will&#xD;
      recruit both males and females above the age of 21 years who consent to provide anonymised&#xD;
      data online on recent changes to their taste and smell. There will be no intervention&#xD;
      (medication or foods) as part of this study. Potential participants will be screened to&#xD;
      ensure they meet the study inclusion and exclusion criteria and all participants will sign an&#xD;
      informed consent.&#xD;
&#xD;
      During their first recruitment session at the hospital/clinic, participants will be required&#xD;
      to complete a series of questionnaires to record recent changes in taste and smell&#xD;
      sensitivity. The series of questionnaires will include: Singapore Smell and Taste&#xD;
      Questionnaire (SSTQ), Sino-nasal Outcome Test-22 (SNOT-22) and optionally, the Global&#xD;
      Consortium of Chemosensory Research Questionnaire (GCCRQ). The purpose of administering the&#xD;
      different questionnaires is to cover wide range of complementary questions that capture&#xD;
      information related to changes in taste and smell function associated with COVID-19&#xD;
      infection. Thereafter participants will be briefed on how to complete the home-use&#xD;
      standardized smell and taste test (Home-use Test). The Home-use Test (HUT) will be completed&#xD;
      daily over a 28 day period at participants place of residence, to enable self-monitoring of&#xD;
      changes to smell and taste abilities. During the HUT, participants will rate their sense of&#xD;
      smell using the two standardised odour pens they are provided on the first day of their&#xD;
      session at the hospital/ clinic. For each pen, participants will be asked to identify the&#xD;
      odour and rate the perceived intensity. This will then be followed a taste test where&#xD;
      participants will take a small quantity of a powder representing each of the four&#xD;
      prototypical basic tastes sweet (sugar), salt (table salt), bitter (coffee powder or tea) and&#xD;
      sour (lime powder), to the tip end of their tongue with a small spoon to taste. Participant&#xD;
      are asked to self-report that they confirm that can identify the taste quality and to rate&#xD;
      the perceived intensity on line scales provided in an online questionnaire. All measures are&#xD;
      self-administered and completed independently by the participant, with responses captured&#xD;
      using unique identifier code for each participant through an online software (CompuSense,&#xD;
      Guelph, Ontario). During the 28-day home use test period, once a week participants will be&#xD;
      asked to complete a 'Follow-up Questionnaire' which will assess how the symptoms experienced&#xD;
      have impacted their enjoyment of food, appetite and food-related quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Actual">June 15, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Taste and smell acuity</measure>
    <time_frame>28 days</time_frame>
    <description>Taste and smell functions of all participants will be assessed as part of the Home-use Test using taste test items (i.e. sweet: sugar, salty: salt, sour: lime powder and bitter: coffee powder) and odour pens respectively. Participants will identify the taste/smell and rate the perceived intensity on a Visual Analogue Scale (VAS) from 'not strong at all' (0) to 'extremely strong taste/smell' (100). A higher score will indicate greater intensity of taste/smell perceived.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Experienced symptoms, changes in appetite and food-related quality of life</measure>
    <time_frame>28 days</time_frame>
    <description>Experienced symptoms, changes in appetite and food-related quality of life will be assessed as part of the Follow-up questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>COVID-19 Positive (Case)</arm_group_label>
    <description>Participants who were present for COVID-19 screening and their test results will later indicate positive of infection. Participants will complete a one-time assessment of the various online questionnaires (Singapore Smell and Test Questionnaire, Sino-nasal Outcome Test-22, and Global Consortium for Chemosensory Research Questionnaire - Optional) in the hospital/clinic. Taste and smell acuity, as well as experienced symptoms, changes in appetite and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COVID-19 Negative/Other respiratory diseases (Control)</arm_group_label>
    <description>Participants who were present for COVID-19 screening and their test results will later indicate negative of infection. Participants will complete a one-time assessment of the various online questionnaires (Singapore Smell and Test Questionnaire, Sino-nasal Outcome Test-22, and Global Consortium for Chemosensory Research Questionnaire - Optional) in the hospital/clinic. Taste and smell acuity, as well as experienced symptoms, changes in appetite and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home-use Test and Follow-up Questionnaire</intervention_name>
    <description>Prospective tracking of changes in taste and smell acuity, and related changes in appetite, enjoyment of food and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days.</description>
    <arm_group_label>COVID-19 Negative/Other respiratory diseases (Control)</arm_group_label>
    <arm_group_label>COVID-19 Positive (Case)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients present for COVID 19 screening&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 years and above&#xD;
&#xD;
          -  Residing in Singapore for the next 28 days.&#xD;
&#xD;
          -  Possess a mobile device with 4G network and knows how to use mobile apps (i.e. QR&#xD;
             scanner)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Allergic/ intolerant to test items (i.e. fragrances, sugar, salt, coffee or lime&#xD;
             powder)&#xD;
&#xD;
          -  Not agreeable with the study team accessing your medical records&#xD;
&#xD;
          -  For women: Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ciaran Forde, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Nutrition Research Centre, Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Nutrition Research Centre, Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>117599</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Nutrition Research Centre, Singapore</investigator_affiliation>
    <investigator_full_name>Vicki Tan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Olfactory dysfunction</keyword>
  <keyword>Gustatory dysfunction</keyword>
  <keyword>Anosmia</keyword>
  <keyword>Ageusia</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04492904
org study id: 2020/00810
nct id: NCT04492904
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Other
measure: Taste and smell acuity
time frame: 28 days
description: Taste and smell functions of all participants will be assessed as part of the Home-use Test using taste test items (i.e. sweet: sugar, salty: salt, sour: lime powder and bitter: coffee powder) and odour pens respectively. Participants will identify the taste/smell and rate the perceived intensity on a Visual Analogue Scale (VAS) from 'not strong at all' (0) to 'extremely strong taste/smell' (100). A higher score will indicate greater intensity of taste/smell perceived.
measure: Experienced symptoms, changes in appetite and food-related quality of life
time frame: 28 days
description: Experienced symptoms, changes in appetite and food-related quality of life will be assessed as part of the Follow-up questionnaire.
arm group label: COVID-19 Positive (Case)
description: Participants who were present for COVID-19 screening and their test results will later indicate positive of infection. Participants will complete a one-time assessment of the various online questionnaires (Singapore Smell and Test Questionnaire, Sino-nasal Outcome Test-22, and Global Consortium for Chemosensory Research Questionnaire - Optional) in the hospital/clinic. Taste and smell acuity, as well as experienced symptoms, changes in appetite and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days.
arm group label: COVID-19 Negative/Other respiratory diseases (Control)
description: Participants who were present for COVID-19 screening and their test results will later indicate negative of infection. Participants will complete a one-time assessment of the various online questionnaires (Singapore Smell and Test Questionnaire, Sino-nasal Outcome Test-22, and Global Consortium for Chemosensory Research Questionnaire - Optional) in the hospital/clinic. Taste and smell acuity, as well as experienced symptoms, changes in appetite and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days
intervention type: Other
intervention name: Home-use Test and Follow-up Questionnaire
description: Prospective tracking of changes in taste and smell acuity, and related changes in appetite, enjoyment of food and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days.
arm group label: COVID-19 Negative/Other respiratory diseases (Control)
arm group label: COVID-19 Positive (Case)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ciaran Forde, Phd
role: Principal Investigator
affiliation: Clinical Nutrition Research Centre, Singapore
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Clinical Nutrition Research Centre, Singapore
investigator full name: Vicki Tan
investigator title: Principal Investigator
mesh term: COVID-19