Data Collection and Evaluation of OptiBP Under Investigational Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OptiBP Study app.
- Who it may be relevant to
- Registry conditions: General Population. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Data Collection and Evaluation of a Mobile, Machine-learning-based Solution for Blood Pressure Estimation - the OptiBP Study.
Overview
The purpose of this study is to collect data to develop and evaluate the use of state-of-the-art machine learning approaches within a mobile phone application for the estimation of blood pressure.
Detailed description
Participants will simultaneously acquire blood pressure measurements through a cuff-based, automatic, over-the-counter blood pressure monitor on the upper arm, while recording an optical signal through the camera of a smartphone on the tip of the index of the opposite arm.
Interventions
- Device OptiBP Study app
Each participant will use OptiBP Study app to measure their blood pressure optically by applying their fingertip to their smartphone camera, and subsequently enter the blood pressure values obtained by measuring it with their own blood pressure cuff.
Primary outcome measures
- Collect Blood Pressure (BP) data and assess performance of smartphone based BP estimations models [Time frame: 12 months]
Secondary outcome measures (1)
- Safety by assessing inconvenience and adverse events [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
- Live in the United States of America
- Have an Android smartphone
- Have access to an arm-worn blood pressure monitor (cuff)
- Have access to the Google Play store to download the OptiBP study app on their phone
- Be comfortable communicating in written and spoken English
- Be willing and able to provide informed consent to participate in the study
Exclusion criteria
- Known contact dermatitis to nickel/chromium
- Lesion or deficiency on hand, preventing placing a finger on the smartphone camera
- Known dysrhythmia like bigeminy, trigeminy, isolated VPB, atrial fibrillation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Decentralized Trial — Truckee
Identifiers
NCT: NCT06017687 · US Data Collection Study