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Study Information

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 Information
Total Variables: 130
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_raceWhat is your race?
nih_ethnicityAre you of Hispanic or Latino origin? May include Spanish origin.
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_education_yrsHow many years of education have you completed?
nih_zipWhat is your zip code?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_deafAre you deaf or do you have serious difficulty hearing?
nih_blindAre you blind or do you have serious difficulty seeing, even when wearing glasses?
nih_memoryBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions?
nih_walk_climbDo you have serious difficulty walking or climbing stairs?
nih_dress_batheDo you have difficulty dressing or bathing?
nih_errandBecause 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_ynVaping use (Yes or No)
nih_nicotine_ynNicotine use (Yes or No)
nih_alcohol_ynAlcohol use (Yes or No)
nih_asthmaAsthma
nih_cancerCancer
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_chronic_lung_diseaseChronic lung disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_immunosuppressive_conditionImmunosuppressive condition
nih_serious_mental_illnessSerious mental illness
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
nih_coughCough
nih_fever_chillsFever or Chills
nih_diff_breathShortness of breath or difficulty breathing
nih_headacheHeadache
nih_muscle_acheMuscle ache
nih_olfactoryNew loss of taste or smell
nih_fatigueExcessive fatigue
nih_nausea_vomiting_diarrheaNausea, vomiting, or diarrhea
nih_abdom_painAbdominal pain
nih_skin_rashSkin rash
nih_conjunctivitisConjunctivitis
nih_health_statusWould you say that (your) health in general is excellent, very good, good, fair, or poor?
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
abdominal_painAbdominal pain
ageWhat is your age? (Age in years. For babies less than 1 year old, write 0 as the age)
alcohol_useAlcohol Use
asthmaAsthma
blindAre you blind or do you have serious difficulty seeing, even when wearing glasses?
cancerCancer
cardiovascular_diseaseCardiovascular disease
chillsChills
chronic_kidney_diseaseChronic kidney disease
chronic_lung_diseaseChronic lung disease
conjunctivitisConjunctivitis
coughCough
deafAre you deaf or do you have serious difficulty hearing?
diabetesDiabetes
diarrheaDiarrhea
dress_bathe_disDo you have difficulty dressing or bathing?
educationHow many years of education have you completed? (Years of education from 0 - 20+)
employmentAre you employed?
errand_disBecause of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping?
ethnicityAre you of Hispanic or Latino origin?
excessive_fatigueExcessive fatigue
feverFever
headacheHeadache
health_statusWould you say that (your) health in general is excellent, very good, good, fair or poor?
height_feetHeight Feet
height_inchesHeight Inches
hypertensionHypertension
immunosuppressive_conditioImmunosuppressive condition
insuranceWhat kind of health insurance do you have?
memory_disBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions?
muscle_acheMuscle ache
nausea_vomitingNausea/vomiting
new_loss_of_taste_or_smellNew loss of taste or smell
nicotineNicotine Use
pregnancy_statusPregnancy status
raceWhat is your race? Mark one or more boxes.
serious_mental_illnessSerious mental illness
sexWhat is your biological sex assigned at birth?
shortness_of_breath_or_difShortness of breath or difficulty breathing
sickle_cell_diseaseSickle cell disease
skin_rashSkin rash
vapingVaping Use
walking_climbing_disDo you have serious difficulty walking or climbing stairs?
weight_lbsWhat is your weight? (Weight in pounds)
zipZip 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-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002642_Aroma Matching Survey.pdf275.12 KB
Study Documentationphs002642_Protocol_JUL2022.pdf70.87 KB
Study Documentationphs002642_Usability Survey.pdf325.81 KB
Data Files
Total Files: 12
Data Files: 4
Metadata Files: 4
Dictionary Files: 4
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
rad_152_2-04S1_phase1_DATA_transformcopy.csvTabular Data - Harmonizedcsv218
rad_152_2-04S1_phase1_DATA_origcopy.csvTabular Data - Non-harmonizedcsv218
rad_152_2-04S1_phase2_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1059
rad_152_2-04S1_phase2_DATA_transformcopy.csvTabular Data - Harmonizedcsv1059