A Study Of CUFFLESS PHOTOPLETHYSMOGRAPHY

Overview

About this study

The purpose of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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 elligible to participate if standard cuff-based ABPM monitor can capture blood pressure at initialization.

Exclusion Criteria:

  • Indication for ABPM is orthostatic hypotension or POTS (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.

  • Average absolute difference between the two arms is greater than 15 mmHg for SBP or greater than 10 mmHg DBP during the initialization/calibration phase.

  • Subjects with known allergy to “stickers” or skin patches.

  • Subjects with solid dark tattoos on the area where the PPG-based device is attached.

  • Subjects who are unwilling to have their chest hair shaved, if needed, to install the device (the device uses stickers and needs to be in direct contact with the skin without hair)

  • Subjects who are unwilling to comply with the study instructions (avoid vigorous exercise and showering for 24 hours while the device is in place)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/05/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Sayeed Khalillullah, M.D.

Open for enrollment

Contact information:

Betty Monari

4805742641

monari.betty@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Lyle Baker, M.D.

Open for enrollment

Contact information:

Muhammad Farooq

9049532255

farooq.muhammad@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Ziad Zoghby, M.D., M.B.A.

Open for enrollment

Contact information:

Travis Nusbaum

5075386379

nusbaum.travis@mayo.edu

More information

Publications

Publications are currently not available