Wearable Assisted Viral Evidence (WAVE) Study A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and Respiratory Viral Infections

The goal of this decentralized, observational study is to enroll and observe adults in the contingent United States during the 2023-2024 flu season. The main study objectives are to create a dataset of paired wearable data, self-reported symptoms, and respiratory viral infection (RVI) from PCR testing during the 2023-2024 flu season and to develop algorithm that is able to accurately classify asymptomatic and symptomatic RVI and understand the algorithm's performance metrics.

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Key information

Conditions

Influenza, Human COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza A Influenza B Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Syncytial Virus (RSV) Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evidation Health

San Mateo, California, 94402, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Lives in the United States
Speaks, reads, and understands English
Currently owns and uses a consumer wearable device (Apple Watch, Garmin, or Fitbit) with necessary step and heart rate data at minimum or willing to wear a study-provided device and download the Fitbit app
Willing to connect their wearable device to the Evidation platform and wear it daily for at least 10 hours for the duration of the study
Owns a smartphone with Apple iOS 15 installed or higher OR Android version 9.0 installed or higher or willing to update
Willing to respond to daily and weekly questionnaires for a 10-week period
Willing to complete at-home nasal swab tests and return the nasal swab samples within 24 hours of being asked to complete it
Meets data density requirements for wearable devices

Exclusion criteria

Self reported diagnosis of both flu and COVID by a healthcare professional or using an at-home test in the past 3 months
Currently enrolled in another interventional study to prevent or treat COVID-19 or another flu-related program being conducted by Evidation (individuals currently participating in Evidation's FluSmart program will be told that their participation will be paused)
Has a primary mailing address that is a P.O box, Army Post Office (APO), Fleet Post Office (FPO), or Diplomatic Post Office (DPO) address, or U.S. military base located overseas, or U.S. territories (Puerto Rico, U.S. Virgin Islands, Guam, Northern Mariana Island, or American Samoa)

Treatment and study plan

Primary outcomes

The primary objectives are to develop a dataset of paired wearable data, self-reported symptoms, and confirmed respiratory viral infection and use the dataset to develop an algorithm to classify asymptomatic/symptomatic RVIs

Time frame: Through study completion, approximately 10 months

This study will gather wearable device data, including heart rate, sleep, activity, and other data types from commercially available wearable activity trackers and smartwatches (e.g. Apple Watch, Fitbit, Garmin devices), as well as self-reported data related to the experience of symptoms associated with respiratory viral infections, and pair this data with the results from PCR tests of serial at-home nasal swabs for SARS-CoV-2, Influenza A, Influenza B, and respiratory syncytial virus (RSV). This data will be used to determine if these data types can be used to develop an algorithm for classifying asymptomatic and symptomatic RVI. Algorithm performance will be assessed across a variety of dimensions including ROC AUC, sensitivity, specificity, PPV, and NPV.

Secondary outcomes

The secondary objective of this observational study is to determine if algorithm performance differs across various demographic groups

Time frame: Through study completion, approximately 10 months

We will test algorithm performance for various different groups of participants to better understand if the algorithm performs difference depending on participant demographics. For example, we will test for performance metrics across different subgroups related to gender, ethnicity, and age. For each subgroup, we will report on ROC AUC, sensitivity, specificity, PPV, and NPV. as appropriate.

Sponsors and collaborators

Lead sponsor

Evidation Health

Industry

Collaborators

Biomedical Advanced Research and Development Authority

Registry information

Acronym: WAVE

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 17, 2024
Registry last updated: Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed