Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
- Conditions
- Blood Pressure
- Registration Number
- NCT06574113
- Lead Sponsor
- Perin Health Devices
- Brief Summary
This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).
- Detailed Description
The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 85
- Adults aged 18 years or older,
- Willing and able to provide informed consent,
- Able to comply with study procedure.
- Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference > 42 cm),
- Patient with a pacemaker,
- History of reactions to medical adhesives,
- Inability to comply with the study procedure,
- Non-English Speaker.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cuffless blood pressure measurement performance 3 months Calculate the mean error and standard deviation of blood pressure (BP) measurements from the PHP relative to the ambulatory blood pressure cuff and determine compliance of the PHP's performance with AAMI standards and ISO 81060-2.
- Secondary Outcome Measures
Name Time Method Demographic performance variance 3 months Determine any variations in performance on certain demographic groups, including subjects who are overweight, subjects with dark skin pigmentation, or subjects with comorbidities.
Trial Locations
- Locations (1)
Perin Health Devices
🇺🇸Woodland Hills, California, United States