Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06207929
Other study ID # WAVE Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 21, 2024
Est. completion date May 2024

Study information

Verified date February 2024
Source Evidation Health
Contact Ernesto Ramirez, PhD
Phone 415-650-4741
Email wavestudy@evidation.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Read more »

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Evidation Health San Mateo California

Sponsors (2)

Lead Sponsor Collaborator
Evidation Health Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

References & Publications (10)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Through study completion, approximately 10 months
Secondary The secondary objective of this observational study is to determine if algorithm performance differs across various demographic groups 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. Through study completion, approximately 10 months
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure