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Acute Respiratory InfectionARSNCT04912180

Apple Respiratory Study

An observational study of Acute Respiratory Infection and Coronavirus Infection, run by Apple Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The Apple Respiratory Study, a collaboration between researchers at Apple Inc. (the "Study Sponsor" or "Sponsor") and the Seattle Flu Study team at the University of Washington (UW) (the "UW Study Team"), is a prospective, longitudinal cohort, low risk Study to collect certain data from Apple Watch and iPhone to… Read more about this study

Who is it for?
Ages 22 years and olderHealthy volunteers can take part
How many people
108 participants
Where
1 siteUnited States
Study dates
6 Apr 2021to 9 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The Study aims to enroll up to 1000 adults. We estimate that we will detect approximately 70 laboratory confirmed influenza cases and 40 laboratory confirmed SARS-CoV-2 cases based on estimated event rate incidences.

Who may be able to join

  • To participate in this Study, individuals must:
  • Have access to an iPhone 6s or later with compatible iOS as defined by the Apple App Store.
  • Have regular and reliable internet access
  • Be willing to comply with all Study procedures, including regular use of the Apple Watch (daytime and nighttime), complete the REDCap and Apple Research app surveys, share data from required Apple Watch and iPhone sensors, and perform self-collected nasal swabs
  • Be able to read and comprehend English
  • Be able to provide informed consent without the use of a legally authorized representative
  • Have a permanent mailing address in the greater Seattle area where Study materials can be mailed
  • Be at least 22 years old at the time of consent

Who cannot join

  • To participate in this Study, individuals must not:
  • Have previously tested positive for SARS-CoV-2 via PCR or antibody test
  • Currently be enrolled in University of Washington Husky Coronavirus Testing, Household Observation Study, or any other Seattle Flu Study sub-Study
  • Have received any vaccine for COVID-19 or have an upcoming appointment for at least one dose of any COVID-19 vaccine prior to Study consent
  • Individuals also may be excluded from the Study once target participant counts have been achieved for certain demographics, comorbidity groups, and/or residence based on zip code

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Apple Respiratory Study: A Prospective Study of Apple Watch-based Detection of Respiratory Viral Illness in Greater Seattle, WA

The Apple Respiratory Study, a collaboration between researchers at Apple Inc. (the "Study Sponsor" or "Sponsor") and the Seattle Flu Study team at the University of Washington (UW) (the "UW Study Team"), is a prospective, longitudinal cohort, low risk Study to collect certain data from Apple Watch and iPhone to determine whether such data can detect physiologic and non-physiologic changes in individuals associated with respiratory illnesses due to influenza, SARS-CoV-2 and other respiratory pathogens (the "Study").

Read the detailed description

Initial Screening and Study enrollment will begin in 2021 among adults residing in the Greater Seattle area. Participants will be recruited and driven to the online Study Website managed by UW. If determined to be eligible following completion of the Prescreen Consent and an initial eligibility assessment via REDCap, potential participants will be asked to review and, if interested in participation, to complete the Main Study Consent via REDCap, as well as to engage in enrollment procedures across both REDCap and the Apple Research app. Redcap will be used for prescreening, enrollment survey, and kit activation survey. Participants will use the Apple Research app to complete onboarding surveys, weekly symptom surveys, illness follow-up surveys, and monthly lifestyle surveys. These surveys will help the investigators learn about onset of respiratory symptoms as well as sick contacts, flu and/or COVID-19 vaccination and risk factors for illness. Participants will also receive an Apple Watch to capture certain sensor data-which, along with iPhone sensor data, will be correlated with symptom onset and symptom trajectory. If a participant experiences an acute respiratory illness (ARI), defined as at least one respiratory symptom for at least 24 hours, that individual will be asked to complete a symptom onset survey and self-collect an anterior nasal swab, which will be sent to UW Laboratory Medicine for analysis. Participants will be able to access their COVID swab test results using a secure web portal. Additionally, individuals who test positive or inconclusive for SARS-CoV-2 will be notified via phone by the UW Study Team and given instructions as defined by and in accordance with state, local, and national public health guidance.

Medical subject headings
Coronavirus Infections, Influenza, Human

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptomatic individuals that self-report ARI and have a laboratory-confirmed positive test for SARS-CoV-2 and/or influenza within 72 hours

    Proportion of symptomatic individuals that self-report ARI and have a laboratory-confirmed positive test for SARS-CoV-2 and/or influenza by self-swab within 72 hours of symptom onset.

    Measured: Up to 6 months

Secondary outcomes (11)

  1. Self-report ARI and positive test for SARS-CoV-2 and/or influenza within 7 days

    Proportion of symptomatic individuals that self-report ARI and have a laboratory-confirmed positive test for SARS-CoV-2 and/or influenza by self-swab within 7 days of symptom onset.

    Measured: Up to 6 months

  2. Self-report ARI and test positive for other ARI within 7 days of symptom onset

    Proportion of symptomatic individuals that self-report ARI and test positive for another respiratory pathogen by self-swab within 7 days of symptom onset

    Measured: Up to 6 months

  3. Onset of ARI event

    Onset of ARI event defined as date and time of first self-reported symptoms (Day 0)

    Measured: Up to 6 months

  4. Hand washing Sessions

    Completed hand washing sessions per week as detected by Apple Watch

    Measured: Up to 6 months

  5. Measure of Heart Rate

    Measure of Heart Rate in Heart Beats per minute

    Measured: Up to 6 months

  6. Measure of Heart Rate Variability

    Measure of Heart Rate Variability in the standard deviation in the time interval between heart beats in milliseconds over variable periods of time.

    Measured: Up to 6 months

  7. Measure of Blood Oxygen

    Measure of Blood oxygen or oxygen saturation -percentage of hemoglobin in your red blood cells carrying oxygen (taken from Apple Watch)

    Measured: Up to 6 months

  8. Nasal swab sample that returns with no pathogens (viral and bacterial) on the panel

    Pathogen-negative ARI (pathogen not detected by laboratory testing; "pathogen negative ARI" could be due to chronic respiratory diseases, viral clearance, or inadequate sample collection)

    Measured: Up to 6 months

  9. RNaseP and viral CRT values

    RNaseP and viral CRT values for laboratory-confirmed virus positive ARI episodes

    Measured: Up to 6 months

  10. Duration of viral shedding and viral loads

    Duration of viral shedding and viral loads in COVID-positive patients as assessed by four swabs collected over two weeks of follow-up

    Measured: Up to 6 months

  11. ECG Reports

    Wrist-based Electrocardiogram (ECG) from smart watch containing time-series representation of the measured voltage corresponding to heart function over 30 second measurement periods.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2021
  2. Study start6 Apr 2021
  3. Primary completion9 Jun 2021
  4. Study completion9 Jun 2021

Why it stopped: Study endpoints no longer feasible.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04912180
Sponsor's protocol ID
Pro00050502
Other IDs
STUDY00011439/ ARS-2020-001
Acronym
ARS
Status last verified
Jul 2021
First submitted
4 May 2021
Last updated
14 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual study data will not be shared beyond the investigative team, and only available to the sponsor in coded form. These details are outlined in the study protocol.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Respiratory Infection and Coronavirus Infection, run by Apple Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study endpoints no longer feasible.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatic individuals that self-report ARI and have a laboratory-confirmed positive test for SARS-CoV-2 and/or influenza within 72 hours (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04912180.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.

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