Wrist-based Blood Pressure Monitoring Study

Completed

• Conditions: Blood Pressure

• Registration Number: NCT03661112
• Lead Sponsor: Scripps Translational Science Institute

Brief Summary

To observe blood pressure variation in various real-world settings

Detailed Description

This is an observational study, which will utilize a wrist-based blood pressure monitor to explore blood pressure variation in up to 75 participants in various real-world settings. There is no intervention in this study. The study will take place over a 4-week period. During this time, participants will be asked to sample their blood pressures 1) at random times, several times per day; 2) during specific periods of either emotional stress or relaxation; 3) during guided orthostatic testing. Study participants will utilize an application on their smartphones to log the device-measured blood pressures and flag selected blood pressure measurements as either being part of the orthostatic testing or during periods of emotional stress/relaxation. At the close of the study a post-study questionnaire will be sent electronically to each participant.

Study Timeline

• Study First Submitted: 2018-05-03
• Study Start: 2018-05-07
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-07
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Consortium members within the All of Us Research Program
• ≥18 years of age
• Own an iOS or Android device

Exclusion Criteria

• Inability to give informed consent
• <18 years of age
• Inability to understand written English language

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure measurements	4 weeks	The primary endpoint for this study is assessing variability in blood pressure measurements (both systolic and diastolic). Blood pressure measurements will be sought over the course of 4 weeks during the following activities: 1. During waking hours (several times a day for at least 2 days out of the week); 2. Orthostatic maneuvers (seated and then 1 minute after standing up); 3. At times of stress and relaxation.

Trial Locations

Locations (1)

Scripps Translational Science Institute; 🇺🇸 La Jolla, California, United States