๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-11

Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM) (NCT07240831)

Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Biobeat Technologies Ltd.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study aims 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. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.

Who can join: Review the eligibility criteria below.

Location: Cardiology, P.C. โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

  • Cardiology, P.C. โ€” Birmingham, Alabama
  • Mayo Clinic โ€” Scottsdale, Arizona
  • Mayo Clinic โ€” Jacksonville, Florida
  • U Health-University of Miami Health System โ€” Miami, Florida
  • Henry Ford Health System โ€” Detroit, Michigan
  • Mayo Clinic โ€” Rochester, Minnesota
  • HaEmek Hospital โ€” Afula,
  • The Holy Family Hospital Nazareth โ€” Nazareth,
  • Sheba Medical Center โ€” Ramat Gan,
  • Maccabi Healthcare โ€” Tel Aviv,
  • Instituto Auxologico Italiano โ€” Milan,

๐Ÿ“ž Contact the Study Coordinator

Phone: +972546969474

Email: ruthie.caspi@bio-beat.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—