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NCT Number: NCT06574113

Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

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).

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Perin Health Devices

Woodland Hills, California, 91364, United States

Location status: Recruiting

Location contact

Ian McLane, Ph.D.

CONTACT

[email protected]

818-606-9389

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perin Health Patch

Device

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 outcomes

  1. Cuffless blood pressure measurement performance

    Time frame: 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 outcomes

  1. Demographic performance variance

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ian M McLane, Ph.D.

CONTACT

[email protected]

8186069389

Valerie Rennoll, Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Perin Health Devices

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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