Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
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: Perin Health Patch.
- Who it may be relevant to
- Registry conditions: Blood Pressure. 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 →
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Overview
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.
Interventions
- Device Perin Health Patch
The Perin Health Patch (PHP)is a multimodal wearable health patch, which combines auscultation, electrocardiography (ECG), pulse oximetry via photoplethysmography (PPG), bioimpedance (BioZ), skin temperature, and motion and tilt sensors. The PHP integrates multiwavelength PPG (MWPPG) with blue, green, red, and IR LEDs, allowing for precise calculation of PTT, PWV, and related unique parameters, that are used for the calculation of cuffless blood pressure.
Primary outcome measures
- Cuffless blood pressure measurement performance [Time frame: 3 months]
Secondary outcome measures (1)
- Demographic performance variance [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Adults aged 18 years or older,
- Willing and able to provide informed consent,
- Able to comply with study procedure.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Perin Health Devices — Woodland Hills
Identifiers
NCT: NCT06574113 · PHD-001-24