An observational study in Acute Respiratory Infection, Coronavirus Infection and Influenza, sponsored by Apple Inc.. Terminated at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by Apple Inc. · Observational
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").
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 108 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Apple Inc. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
To participate in this Study, individuals must:
Exclusion Criteria:
To participate in this Study, individuals must not:
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
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.
Time frame: Up to 6 months
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.
Time frame: 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
Time frame: Up to 6 months
Onset of ARI event
Onset of ARI event defined as date and time of first self-reported symptoms (Day 0)
Time frame: Up to 6 months
Hand washing Sessions
Completed hand washing sessions per week as detected by Apple Watch
Time frame: Up to 6 months
Measure of Heart Rate
Measure of Heart Rate in Heart Beats per minute
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: Up to 6 months
RNaseP and viral CRT values
RNaseP and viral CRT values for laboratory-confirmed virus positive ARI episodes
Time frame: 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
Time frame: 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.
Time frame: Up to 6 months
Plan to share: 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.
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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