Mobile Study to Measure and Predict Lupus Disease Activity Using Digital Signals (OASIS)

Progentec Diagnostics

Status: Unknown

Conditions: Lupus Erythematosus, Systemic; Lupus Erythematosus

Study type: Observational

Funder types: Industry

Identifiers

NCT04449653

MEASURE

Details and patient eligibility

About

OASIS: A mobile study to measure and predict lupus (SLE) disease activity using digital signals The OASIS study is exploring how patient reported data and digital biomarkers, like activity level and heart rate variability, can be used to predict changes in lupus disease activity. You may receive a Withings Steel HR smartwatch as part of this study. The purpose of this study is to look for factors that affect lupus disease activity and potentially predict lupus flares through non-clinical tests

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female or male age 18 or older
• Participant is currently not enrolled in another study
• Able to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures

Exclusion criteria

• NOT able to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures
• Known to be pregnant

Trial design

300 participants in 1 patient group

Lupus Cases

Description:

Individuals who are diagnosed with System Lupus Erythematosus and consent to the study will be placed in this cohort. Upon enrollment they will be given the opportunity to invite a non-SLE-diagnosed friend to enroll in the study as a healthy control. These individuals will answer weekly questions and receive a smartwatch to measure their physical activity.