Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
Study Details
Study Description
Brief Summary
The purpose of this study is to learn more about how to better identify people who have been infected with the SARS-CoV-2 virus (which causes COVID-19). Most people who have been exposed to the 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. The impact of smell testing to identify people at risk for SARS-CoV-2 will be maximized if objective and precise olfactory testing can be performed in the convenience of one's home. We will use results from this test to better understand the relationship between SARS-CoV-2 and olfactory function and to learn whether the AROMHA longitudinal smell test is a reliable screening tool to detect smell loss in the context of possible COVID exposure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Anosmic patients 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. |
Device: AROMHA Longitudinal Smell Test
The AROMHA Longitudinal Smell Test is a self-administered, at-home smell test intended for use as a screening test by asymptomatic individuals to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19, through a serial testing approach. The device consists of six versions of a smell card, each containing three unique odors.
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| Asymptomatic participants / Healthy participants 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. |
Device: AROMHA Longitudinal Smell Test
The AROMHA Longitudinal Smell Test is a self-administered, at-home smell test intended for use as a screening test by asymptomatic individuals to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19, through a serial testing approach. The device consists of six versions of a smell card, each containing three unique odors.
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| Symptomatic participants Symptomatic individuals will be recruited from respiratory illness clinics to evaluate smell function in patients with either SARS-CoV2, Influenza, or Adenovirus infection. All consent and testing will occur on a phone/tablet app in the participant's home. |
Device: AROMHA Longitudinal Smell Test
The AROMHA Longitudinal Smell Test is a self-administered, at-home smell test intended for use as a screening test by asymptomatic individuals to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19, through a serial testing approach. The device consists of six versions of a smell card, each containing three unique odors.
|
Outcome Measures
Primary Outcome Measures
- Aromha Longitudinal Smell Test [6 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. We will evaluate previously diagnosed anosmic patients.
- Aromha Longitudinal Smell Test [6 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 score on the olfactory test will be compared to the PCR results (SARS-CoV-2 negative or positive) of asymptomatic and symptomatic individuals.
Secondary Outcome Measures
- Brief Smell Identification Test (BSIT) [6 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.
Other Outcome Measures
- Comparison of Aromha Longitudinal Smell Test results with upper respiratory illness [6 weeks]
To compare results of the Aromha Longitudinal smell test with test results of upper respiratory illnesses such as Influenza and Adenovirus.
- Comparison of Aromha Longitudinal Smell Test results with vaccination status [6 weeks]
To compare results of the Aromha Longitudinal smell test will self-reported vaccination status
Eligibility Criteria
Criteria
For anosmic patients/healthy controls:
Inclusion criteria
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Known anosmia (for anosmic patients only)
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Age greater than or equal to 18
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Access to phone, tablet or computer connected to the internet.
Exclusion criteria
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Known odor-evoked adverse effects, e.g. asthma.
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No known history of SARS-CoV-2 and or other respiratory illness (healthy controls only)
For asymptomatic participants:
Inclusion criteria
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No symptoms of COVID infection at the time of enrollment.
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Age greater than or equal to 18
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Access to phone, tablet or computer connected to the internet.
Exclusion criteria
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Known odor-evoked adverse effects, e.g. asthma.
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Prior known smell or taste disorder
For symptomatic patients:
Inclusion criteria
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Potential or definite exposure to SARS-CoV-2 virus
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Symptoms of upper respiratory infection (smell loss, taste loss, fever, myalgia, cough, nasal congestion, runny nose, shortness of breath)
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Age greater than or equal to 18
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Access to phone, tablet or computer connected to the internet.
Exclusion criteria
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Known odor-evoked adverse effects, e.g. asthma.
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Prior known smell or taste disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02129 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
- Principal Investigator: Mark W Albers, MD PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021P001988
- U01DC019579