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NCT Number: NCT05040659

Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anosmia Asymptomatic COVID-19 COVID-19 COVID-19 Respiratory Infection Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Healthy Infections Influenza Influenza, Human Lung Diseases Nervous System Diseases Neurologic Manifestations Nidovirales Infections Olfaction Disorders Orthomyxoviridae Infections PASC Post Acute Sequelae of COVID 19 Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Signs and Symptoms Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For anosmic patients/healthy controls:

Inclusion criteria

  • Known anosmia (for anosmic patients only)
  • Age greater than or equal to 18
  • Access to phone, tablet or computer connected to the internet.

Exclusion criteria

  • Known odor-evoked adverse effects, e.g. asthma.

For asymptomatic participants:

Inclusion criteria

  • No symptoms of COVID infection at the time of enrollment.
  • Age greater than or equal to 18
  • Access to phone, tablet or computer connected to the internet.

Exclusion criteria

  • Known odor-evoked adverse effects, e.g. asthma.

For participants with COVID-19-related smell loss:

Inclusion criteria

  • Past infection of SARS-CoV-2 virus as validated by a previous PCR or antigen test
  • Age greater than or equal to 18
  • Access to phone, tablet or computer connected to the internet.

Exclusion criteria

  • Known odor-evoked adverse effects, e.g. asthma.

Treatment and study plan

AROMHA Longitudinal Smell Test

Device

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.

Primary outcomes

  1. Aromha Longitudinal Smell Test

    Time frame: 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. We will evaluate previously diagnosed anosmic patients.

  2. Aromha Longitudinal Smell Test

    Time frame: 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 outcomes

  1. Brief Smell Identification Test (BSIT)

    Time frame: 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.

Other outcomes

  1. Comparison of Aromha Longitudinal Smell Test results with upper respiratory illness

    Time frame: 12 weeks

    To compare results of the Aromha Longitudinal smell test with test results of upper respiratory illnesses.

  2. Comparison of Aromha Longitudinal Smell Test results with vaccination status

    Time frame: 12 weeks

    To compare results of the Aromha Longitudinal smell test with self-reported vaccination status.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Sep 10, 2021
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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