dbGaP Study Accession: phs002642
NIH Institute/Center: NIDCD
RADx Data Program: RADx-rad
Release Date: 11/07/2022
DOI: 10.60773/sqkn-3a50
Study Description: The goals of this Emergency Competitive Revision were to develop (Aim 1) and deploy (Aim 2) a novel, objective, psychophysical smell and taste screening test to detect the onset of COVID-19 in at-risk populations. Complementary to the temperature screening procedures currently in use, this tool was predicted to promote early identification of COVID onset, leading to better prognoses and the early implementation of protocols to prevent community spread. A hard-candy containing different combinations of tastants and flavors that were easy to distribute to a large population were used. During the development phase (Aim 1), this novel test was compared with the NIH toolbox to assess the acceptability and efficacy of the two methods. It was expected that the hard-candy assessment would be at least as efficacious in detecting chemosensory loss but more acceptable to subjects. Aim 2 entailed daily self-monitoring of chemosensory function in at-risk populations with data tracked through a secure online portal. The novelty of this confectionary-based test was that it provided standard stimuli that can yield objective measures of both the qualitative and quantitative aspects of smell (aroma and flavor) and taste (sweet and sour). Moreover, both orthonasal and retronasal olfactory function were independently assessed. The test can be self-administered and the familiar, pleasant nature of the stimuli facilitated a high compliance rate, allowing for continuous monitoring over prolonged periods. Moreover, the test was rapid and inexpensive. Data were incorporated into a predictive model for COVID-19 and assessed using AOC analyses of sensitivity and specificity. OSU is a leading large public land grant university with a varied population of students, faculty, and support staff that includes all health care specialties. These characteristics, along with the University-mandated regular PCR testing of students and staff made it a perfect site to perform this urgent research.
Updated Date: 12/09/2022
Principal Investigator: Travers, Susan P
Has Data Files: Yes
Study Domain: Medical Device or Tool Development; Rapid Diagnostic Test (RDT)
Data Collection Method: Chemosensory Testing Device
Keywords: Flavor; Olfactory Function; Orthonasal; Psychophysical Smell and Taste Screening; Retronasal; Smell; Taste
Study Design: Longitudinal Cohort
Multi-Center Study: No
Data Types: Questionnaire or Survey
Study Start Date: 12/21/2020
Study End Date: 03/31/2023
Species: Human
Estimated Cohort Size: 2750
Study Population Focus: Adults
Acknowledgement Statement: This study was supported through funding, 3R01DC016112-04S1, for the National Institute on Deafness and Other Communication Disorders (NIDCD) as part of the RADx-rad program. This work was supported with Principal Investigator Dr. Susan Travers and co-investigators Dr. Chris Simons and Dr. Kai Zhao. A special acknowledgment to our study team, research staff, and the study participants that made this project possible. Approved users should acknowledge the provision of data access by dbGaP for accession phs002642.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.
Funding Opportunity Announcement (FOA) Number: PA-20-135
NIH Grant or Contract Number(s): 3R01DC016112-04S1
Consent/Data Use Limitations: General Research Use
Variable Name | Label |
---|---|
nih_record_id | User ID |
nih_race | What is your race? |
nih_ethnicity | Are you of Hispanic or Latino origin? May include Spanish origin. |
nih_age | What is your age? |
nih_sex | What is your biological sex assigned at birth? |
nih_education_yrs | How many years of education have you completed? |
nih_zip | What is your zip code? |
nih_employment | Please specify your employment status. |
nih_insurance | What kind of health insurance do you have? |
nih_deaf | Are you deaf or do you have serious difficulty hearing? |
nih_blind | Are you blind or do you have serious difficulty seeing, even when wearing glasses? |
nih_memory | Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? |
nih_walk_climb | Do you have serious difficulty walking or climbing stairs? |
nih_dress_bathe | Do you have difficulty dressing or bathing? |
nih_errand | Because of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping? |
nih_vaping_yn | Vaping use (Yes or No) |
nih_nicotine_yn | Nicotine use (Yes or No) |
nih_alcohol_yn | Alcohol use (Yes or No) |
nih_asthma | Asthma |
nih_cancer | Cancer |
nih_cardiovascular_disease | Cardiovascular disease |
nih_chronic_kidney_disease | Chronic kidney disease |
nih_chronic_lung_disease | Chronic lung disease |
nih_diabetes | Diabetes |
nih_hypertension | Hypertension |
nih_immunosuppressive_condition | Immunosuppressive condition |
nih_serious_mental_illness | Serious mental illness |
nih_sickle_cell_disease | Sickle cell disease |
nih_pregnancy | Pregnancy status |
nih_cough | Cough |
nih_fever_chills | Fever or Chills |
nih_diff_breath | Shortness of breath or difficulty breathing |
nih_headache | Headache |
nih_muscle_ache | Muscle ache |
nih_olfactory | New loss of taste or smell |
nih_fatigue | Excessive fatigue |
nih_nausea_vomiting_diarrhea | Nausea, vomiting, or diarrhea |
nih_abdom_pain | Abdominal pain |
nih_skin_rash | Skin rash |
nih_conjunctivitis | Conjunctivitis |
nih_health_status | Would you say that (your) health in general is excellent, very good, good, fair, or poor? |
nih_height | What is your height in inches? |
nih_weight | What is your weight in pounds? |
abdominal_pain | Abdominal pain |
age | What is your age? (Age in years. For babies less than 1 year old, write 0 as the age) |
alcohol_use | Alcohol Use |
asthma | Asthma |
blind | Are you blind or do you have serious difficulty seeing, even when wearing glasses? |
cancer | Cancer |
cardiovascular_disease | Cardiovascular disease |
chills | Chills |
chronic_kidney_disease | Chronic kidney disease |
chronic_lung_disease | Chronic lung disease |
conjunctivitis | Conjunctivitis |
cough | Cough |
deaf | Are you deaf or do you have serious difficulty hearing? |
diabetes | Diabetes |
diarrhea | Diarrhea |
dress_bathe_dis | Do you have difficulty dressing or bathing? |
education | How many years of education have you completed? (Years of education from 0 - 20+) |
employment | Are you employed? |
errand_dis | Because of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping? |
ethnicity | Are you of Hispanic or Latino origin? |
excessive_fatigue | Excessive fatigue |
fever | Fever |
headache | Headache |
health_status | Would you say that (your) health in general is excellent, very good, good, fair or poor? |
height_feet | Height Feet |
height_inches | Height Inches |
hypertension | Hypertension |
immunosuppressive_conditio | Immunosuppressive condition |
insurance | What kind of health insurance do you have? |
memory_dis | Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? |
muscle_ache | Muscle ache |
nausea_vomiting | Nausea/vomiting |
new_loss_of_taste_or_smell | New loss of taste or smell |
nicotine | Nicotine Use |
pregnancy_status | Pregnancy status |
race | What is your race? Mark one or more boxes. |
serious_mental_illness | Serious mental illness |
sex | What is your biological sex assigned at birth? |
shortness_of_breath_or_dif | Shortness of breath or difficulty breathing |
sickle_cell_disease | Sickle cell disease |
skin_rash | Skin rash |
vaping | Vaping Use |
walking_climbing_dis | Do you have serious difficulty walking or climbing stairs? |
weight_lbs | What is your weight? (Weight in pounds) |
zip | Zip or Postal Code: (De-Identified zip code) |
address_state | - |
booster | - |
booster_date | - |
booster_number | - |
booster_type | - |
Code | - |
confirmed | - |
confirmed.1 | - |
covid_pos | - |
covid_pos_2 | - |
Covid_Survey_Date | - |
cs_confirm | - |
cs_confirm_1st | - |
cs_fat_severity | - |
cs_fat_severity_1st | - |
cs_hospital | - |
cs_hospital_1st | - |
cs_hos_tx | - |
cs_hos_tx_3rd | - |
cs_how_feel_v2 | - |
cs_past_sx | - |
cs_past_sx_1st | - |
cs_sob_severity | - |
cs_sob_severity_1st | - |
cs_suspect | - |
cs_temperature_v2 | - |
date_vaccine_1 | - |
date_vaccine_2 | - |
days_vaccine | - |
dx_covid | - |
If_you_are_able_to_measure_it,_what_is_your_temperature? | - |
nih_record_id | - |
other_sx_des_1st | - |
other_symp | - |
other_symp_1st | - |
other_symp_1st.1 | - |
Please_describe_these_symptoms..3 | - |
pregnancy_status_a51e67 | - |
prior_smell_or_taste_disor | - |
Prior_smell_or_taste_disorder_(non-COVID-related) | - |
study_id | - |
study_id | - |