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OpenTrials
Completed

NCT Number: NCT03661112

Wrist-based Blood Pressure Monitoring Study

To observe blood pressure variation in various real-world settings

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Translational Science Institute

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Blood pressure measurements

    Time frame: 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:

    • During waking hours (several times a day for at least 2 days out of the week)
    • Orthostatic maneuvers (seated and then 1 minute after standing up)
    • At times of stress and relaxation.

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Collaborators

  • Omron Healthcare Co., Ltd.

Registry information

Official study title

A Pilot Study to Explore the Feasibility and Operational Pathways of Incorporating a Wrist-based Blood Pressure Monitoring Device Into the All of Us Research Program

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2018
Registry last updated
Jan 8, 2019

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.

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