dbGaP Study Accession: phs002699

NIH Institute/Center: NIDCD

RADx Data Program: RADx-rad

Release Date: 11/07/2022

DOI: 10.60773/3v5j-f685

Study Description: Smell loss is a predominant symptom of COVID-19, and initial evidence based on self-reports suggests that chemosensory loss is a sensitive predictor of COVID-19 in the general population, more so than fever. However, given the natural lack of awareness of chemosensory changes, self-reports underestimate the true prevalence of smell loss in patients with COVID-19 by 20% compared to an objective test. Therefore, this study examined testing and deploying a rapid and objective measure of smell ability, the SCENTinel test, inspired by the NIH Toolbox Odor Identification Test. SCENTinel was an inexpensive, convenient, and robust smell test for COVID-19 surveillance of the population that quickly and easily assesses three smell loss factors: odor detection, odor intensity, and odor identification. It was designed for practical use in several contexts, including high-density areas such as community medical sites, universities, subacute care facilities, and both industrial and nonindustrial workplaces. The multi-disciplinary team had expertise in understanding taste and smell, developing and validating chemosensory tests, as well as studying the broad symptomatology of COVID-19. This project aimed to a) fine-tune SCENTinel's ability to predict a positive COVID-19 diagnostic test; b) examine marginal smell loss as a sign of the earliest phases of COVID-19, before a positive diagnostic test; and c) assess the test's psychometric validity with test-retest reliability measures and validation against the NIH Toolbox Odor Identification Test. Together, these aims established a standardized protocol for use of SCENTinel as a rapid and objective smell test that can easily be incorporated into onsite COVID-19 testing centers, schools, and workplaces nationwide. Furthermore, it provided key insights into early-onset chemosensory symptoms in relation to a confirmed COVID-19 diagnosis, providing a crucially needed means to contain the spread of COVID-19.

Updated Date: 01/18/2024

Principal Investigator: Dalton, Pamela Helen

Has Data Files: No

Study Domain: Medical Device or Tool Development

Data Collection Method: Chemosensory Testing Device

Keywords: Anosmia; Odor Detection; Odor Identification; Odor Intensity; Olfactory Dysfunction; Prevalence of Smell Loss; Psychometric Validity; Smell Ability; Symptomatology

Study Design: Case-Control

Multi-Center Study: No

Study Sites: Monell Chemical Senses Center; Temple University; Northwestern University; Fox Subacute Care; University of Pennsylvania; University of Dayton; Yale University; Kids (Frankford Friends; Springside Chestnut Hill Academy)

Data Types: Behavioral; Electronic Medical Records; Questionnaire or Survey

Study Start Date: 12/21/2020

Study End Date: 02/28/2022

Species: Human Data

Estimated Cohort Size: 16360

Study Population Focus: N/A

Publication URL: https://pubmed.ncbi.nlm.nih.gov/33773496/; https://pubmed.ncbi.nlm.nih.gov/35350197/; https://pubmed.ncbi.nlm.nih.gov/36796784/; https://pubmed.ncbi.nlm.nih.gov/37333099/

Acknowledgement Statement: This study was supported through funding, 4U01DC019578-02, for the National Institute on Deafness and Other Communication Disorders (NIDCD) as part of the RADx-rad program. We would like to acknowledge the SCENTinel team at the Monell Chemical Senses Center and Temple University for their efforts in creating SCENTinel and collecting this data: Pamela Dalton, Valentina Parma, Mackenzie Hannum, Dani Reed, Maureen O'Leary, and Stephanie Hunter, with help from Jenifer Trachtman, Alyssa Wofford, Karen Kreeger, Steven Rowe, Dennis Coleman, Kathleen Bell, Matt Carr, Ronald Schwoyer, Carol Christensen, Chris Maute, Riley Herriman, and Heather Cavison. We would also like to acknowledge researchers at Northwestern University, University of Pennsylvania, and Fox Subacute Care for their data collection efforts. We acknowledge Mark Bernstein and Megan Hansen from Scentisphere Inc. for the manufacture of SCENTinel, and the Monell Center and NIDCD for funding this research. Approved users should acknowledge the provision of data access by dbGaP for accession phs002699.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: RFA-OD-20-022

NIH Grant or Contract Number(s): 4U01DC019578-02

Consent/Data Use Limitations: General Research Use