Apple Respiratory Study: A Prospective Study of Apple Watch-based Detection of Respiratory Viral Illness in Greater Seattle, WA
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Apple Inc.
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Symptomatic individuals that self-report ARI and have a laboratory-confirmed positive test for SARS-CoV-2 and/or influenza within 72 hours
研究概览
简要总结
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").
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Symptomatic individuals that self-report ARI and have a laboratory-confirmed positive test for SARS-CoV-2 and/or influenza within 72 hours
时间窗: Up to 6 months
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.
次要结局
- Measure of Blood Oxygen(Up to 6 months)
- Hand washing Sessions(Up to 6 months)
- Measure of Heart Rate(Up to 6 months)
- Self-report ARI and test positive for other ARI within 7 days of symptom onset(Up to 6 months)
- Measure of Heart Rate Variability(Up to 6 months)
- Duration of viral shedding and viral loads(Up to 6 months)
- ECG Reports(Up to 6 months)
- Self-report ARI and positive test for SARS-CoV-2 and/or influenza within 7 days(Up to 6 months)
- Onset of ARI event(Up to 6 months)
- Nasal swab sample that returns with no pathogens (viral and bacterial) on the panel(Up to 6 months)
- RNaseP and viral CRT values(Up to 6 months)