Clinical trial NCT04912180: Apple Respiratory Study
Official title: Apple Respiratory Study: A Prospective Study of Apple Watch-based Detection of Respiratory Viral Illness in Greater Seattle, WA
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Respiratory Infection
Coronavirus Infection
Influenza
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
First posted: 2021-06-03
Enrollment: 108
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief 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 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").

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic individuals that self-report ARI and have a laboratory-confirmed positive test for SARS-CoV-2 and/or influenza within 72 hours
timeFrame: Up to 6 months
Secondary outcomes:
measure: Self-report ARI and positive test for SARS-CoV-2 and/or influenza within 7 days
timeFrame: Up to 6 months
measure: Self-report ARI and test positive for other ARI within 7 days of symptom onset
timeFrame: Up to 6 months
measure: Onset of ARI event
timeFrame: Up to 6 months
measure: Hand washing Sessions
timeFrame: Up to 6 months
measure: Measure of Heart Rate
timeFrame: Up to 6 months
measure: Measure of Heart Rate Variability
timeFrame: Up to 6 months
measure: Measure of Blood Oxygen
timeFrame: Up to 6 months
measure: Nasal swab sample that returns with no pathogens (viral and bacterial) on the panel
timeFrame: Up to 6 months
measure: RNaseP and viral CRT values
timeFrame: Up to 6 months
measure: Duration of viral shedding and viral loads
timeFrame: Up to 6 months
measure: ECG Reports
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Helen Chu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: