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Could a smart wearable spot COVID-19 before symptoms start?

NCT ID NCT05035420

Knowledge-focused Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This pilot study tested a noninvasive wearable device that measures breathing, heart rate, body temperature, and oxygen levels. Researchers wanted to see if it could help screen for and monitor respiratory infections like COVID-19. Forty healthy adults performed breathing tasks while the device was compared to standard monitors. The goal was to validate the device's accuracy, not to treat or diagnose disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
noninvasive multimodal biosensing device
What this could lead to
If successful, this device could offer a simple, wearable way to screen for respiratory infections and monitor recovery at home.
What could go wrong
This is a very small pilot study with only 40 healthy adults, not patients. It tests the device's accuracy in a lab, not real-world use. The device may not work as well in sick people or outside controlled conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

May 2022

Finished

Aug 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 78 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female aged 18 years or greater. * In good general health as evidenced by medical history with no signs of cough, sneeze and upper respiratory symptoms. * Body temperature in normal range (afebrile, temperature \< 100.4 (Infinite) F) on the day of the experiment. EXCLUSION CRITERIA: * Any skin disease. * Fever (Temperature greater than or equal to 100.4 degrees F). * Any past or present cardiovascular or pulmonary diseases. * Known adverse reaction to latex. * Any medical condition that, in the opinion of the Principal Investigator would preclude the inclusion of a patient onto this research study. * Unable or unwilling to give informed consent. * Individuals with known respiratory conditions. * Individuals who are currently taking medication that may cause methemoglobinemia such as nitrates derivatives, sulfonamides, dapsone, phenacetin, phenazopyridine, some local anesthetics such as prilocaine, topical anesthetics such as emla cream, benzocaine. * Individuals with history of seizure. * Smokers and those on narcotics. * Pregnant women are excluded due to risk associated to hypercapnia risk

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Conditions

The condition(s) this trial relates to.

COVID-19 respiratory tract infectious disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 Lower respiratory infection Upper respiratory infection

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.