This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.
Females and Males subjects 18 years or older (from all skin tones/colors)
Scheduled for ABPM for hypertension screening, evaluation, or management
Subjects capable of using an application temporarily downloaded (for the duration of the study) on a personal smart phone device or on a device provided by the study sponsor
Subjects with Atrial fibrillation or Atrial flutter are eligible to participate if standard cuff-based ABPM monitor can capture blood pressure at initialization
Indication for ABPM is orthostatic hypotension or Postural Orthostatic Tachycardiac Syndrome as indicated on the ABPM referral order
Any neurological, psychological, or other condition impairing the ability to provide informed consent or participate in the study
Inability to reliably access the Internet via a smart phone
Not able to perform standard cuff-based ABPM
Single group
Model BB-613WP
DeviceDuring the study period, participants will undergo standard ABPM monitoring per clinical indication and wear a PPG-based monitor
Primary Endpoint
The accuracy and reliability of the PPG-based chest-patch device will be evaluated by comparing its blood pressure measurements with those obtained through the gold-standard upper arm cuff oscillometric ABPM method. Both systolic and diastolic blood pressure values will be assessed.
Secondary Endpoint
Comparison of the compliance and completeness of the 2 measurement methods. The investigators will report the percentage of participants with at least 30% missed data (defining non-compliance or incomplete study).
Secondary Endpoint
Convenience of the device (participants' questionnaire) will be assessed. Participants will rate the experience on a scale of 1 to 5, with 5 indicating a higher satisfaction score for the following questions: 1. Comfort level during placement of the monitor 2. Comfort level during monitoring 3. Interference with sleep 4. Interference with daytime activity (i.e., dressing, ambulating, eating) 5. General satisfaction with the monitoring Additional questions- 6. Which diagnostic option would you recommend to a friend / family member? Options- Biobeat, cuff, either is fine. Answering "Biobeat" will be considered a positive response. 7. In the future, if you undergo monitoring with Biobeat- how would you prefer to receive the monitor? Options- Mailed directly home, applied at the clinic. Either response is acceptable
Other Endpoints (exploratory analyses)
Subgroup analysis based on sex: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed
Other Endpoints (exploratory analyses)
Subgroup analysis based on skin tone: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed
Other Endpoints (exploratory analyses)
Subgroup analysis based on hypertension diagnosis (positive or negative) diagnosed by standard arm-based oscillometric ABPM: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed
Other Endpoints (exploratory analyses)
Subgroup analysis based on participants with atrial fibrillation/atrial flutter: Sensitivity analyses will assess the agreement between systolic and diastolic blood pressure readings (in mmHg) obtained from the Biobeat wearable monitor and the ABPM. Agreement will be evaluated using descriptive statistics and visual methods (e.g., Bland-Altman plots). No formal statistical subgroup comparisons will be performed
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Biobeat Technologies Ltd.
Lead sponsor
Mayo Clinic
Collaborator
