Apple Respiratory Study (ARS)

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").

Study Overview

• Status: Terminated
• Conditions: Coronavirus Infection; Influenza; Acute Respiratory Infection

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.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months
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	Up to 6 months
Onset of ARI event	Onset of ARI event defined as date and time of first self-reported symptoms (Day 0)	Up to 6 months
Hand washing Sessions	Completed hand washing sessions per week as detected by Apple Watch	Up to 6 months
Measure of Heart Rate	Measure of Heart Rate in Heart Beats per minute	Up to 6 months
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.	Up to 6 months
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)	Up to 6 months
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)	Up to 6 months
RNaseP and viral CRT values	RNaseP and viral CRT values for laboratory-confirmed virus positive ARI episodes	Up to 6 months
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	Up to 6 months
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.	Up to 6 months

Collaborators and Investigators

• Sponsor: Apple Inc.
• Collaborators: University of Washington
• Investigators: Principal Investigator: Helen Chu, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): June 9, 2021

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease Attributes; Coronavirus Infections; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: Pro00050502; STUDY00011439/ ARS-2020-001 (Other Identifier: University of Washington Human Subjects Division)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No