Apple Respiratory Study

Influenza Clinical Trial

— ARS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04912180
• Other study ID #: Pro00050502
• Secondary ID: STUDY00011439/ A
• Status: Terminated
• Start date: April 6, 2021
• Est. completion date: June 9, 2021

Study information

• Verified date: July 2021
• Source: Apple Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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").

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• Infection
• Influenza
• Respiratory Tract Infections

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Apple Inc.	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

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