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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05040659
Enrollment
1000
Registered
2021-09-10
Start date
2022-11-14
Completion date
2027-12-31
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anosmia, Asymptomatic COVID-19, COVID-19 Respiratory Infection, Healthy, Influenza, PASC Post Acute Sequelae of COVID 19

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.

Interventions

DEVICEAROMHA 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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

For anosmic patients/healthy controls: Inclusion criteria 1. Known anosmia (for anosmic patients only) 2. Age greater than or equal to 18 3. Access to phone, tablet or computer connected to the internet.

Exclusion criteria

1\. Known odor-evoked adverse effects, e.g. asthma. For asymptomatic participants: Inclusion criteria 1. No symptoms of COVID infection at the time of enrollment. 2. Age greater than or equal to 18 3. Access to phone, tablet or computer connected to the internet.

Design outcomes

Primary

MeasureTime frameDescription
Aromha Longitudinal Smell Test12 weeksThe 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.

Secondary

MeasureTime frameDescription
Brief Smell Identification Test (BSIT)12 weeksThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMark W Albers, MD PhD

Massachusetts General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026