dbGaP Study Accession: phs002642

NIH Institute/Center: NIDCD

RADx Data Program: RADx-rad

Release Date: 11/07/2022

DOI: 10.60773/sqkn-3a50

Updated Date: 12/09/2022

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.

Principal Investigator: Travers, Susan P

Has Data Files: Yes

Study Domain: Medical Device/Tool Development; Rapid Diagnostic Test (RDT)

Data Collection Method: Chemosensory Testing Device

Keywords: Smell; Taste; Retronasal; Orthonasal; Psychophysical Smell and Taste Screening; Olfactory Function; Flavor

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Other; Questionnaires/Surveys

Data Types, Other: Sensory Evaluation

Study Start Date: 12/21/2020

Study End Date: 03/31/2023

Species: Human Data

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