NCT06574113RecruitingAccepts Healthy Volunteers

Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

Perin Health Devices

Start Date

8/15/2024

Completion Date

12/31/2024

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Perin Health Patch

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Conditions

Blood Pressure

Locations

Perin Health Devices

Woodland Hills, California 91364

United States