Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
- Conditions
- COVID-19 Respiratory InfectionAsymptomatic COVID-19HealthyAnosmiaInfluenza
- Interventions
- Device: AROMHA Longitudinal Smell Test
- Registration Number
- NCT05040659
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The purpose of this study is to learn more about how to better track smell recovery in people who have been infected with the SARS-CoV-2 virus (which causes COVID-19). Many people who have been infected by this virus develop changes in their sense of smell (olfaction). We are interested in measuring smell function objectively via smell cards that test odor intensity, identification, and discrimination. Objective and precise olfactory testing that can be performed in the convenience of one's home will help identify people with smell loss after infection by SARS-CoV-2. We will use results from this test to better understand the relationship between SARS-CoV-2 infection and recovery of olfactory function and to learn whether the AROMHA longitudinal smell test is a reliable olfactory function tracking tool to quantify smell loss in the context of COVID infection. These results may inform the design of therapeutic clinical trials to accelerate the recovery of smell function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Anosmic patients AROMHA Longitudinal Smell Test Anosmic patients will be recruited from Dr. Albers Smell Clinic at MGH and through past participation in research with known anosmia and permission to recontact. All consent and testing will occur on a phone/tablet app in the participant's home. Asymptomatic participants / Healthy participants AROMHA Longitudinal Smell Test Asymptomatic participants recruited in a hospital setting (eg. healthcare workers and household members of symptomatic patients who are potentially COVID positive). No symptoms of COVID infection at the time of enrollment. Potential or definite exposure to SARS-CoV-2 virus without symptoms of upper respiratory infection (smell loss, taste loss, fever, myalgia, cough, nasal congestion, runny nose, shortness of breath). All consent and testing will occur on a phone/tablet app in the participant's home. Participants with a confirmed COVID-19 infection or related smell loss AROMHA Longitudinal Smell Test Individuals who tested positive for SARS-CoV2 by an objective PCR or antigen test will be recruited to evaluate smell function weekly over 3 months. All consent and testing will occur on a phone/tablet app in the participant's home.
- Primary Outcome Measures
Name Time Method Aromha Longitudinal Smell Test 12 weeks The Aromha Smell Test is a battery of 18 odors across 6 smell cards. The subject smells each of the 3 scents per card to determine smell intensity, identification, and discrimination. Increased number of correct responses indicates better sense of smell. The subject's scores on the longitudinal olfactory tests will be compared to the self-reported COVID test results (SARS-CoV-2 negative or positive) of asymptomatic and symptomatic individuals.
- Secondary Outcome Measures
Name Time Method Brief Smell Identification Test (BSIT) 12 weeks The BSIT is a battery of 12 odors with a score range from 0-12. Higher scores indicate a better sense of smell. We will evaluate previously diagnosed anosmic patients and healthy asymptomatic controls.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States