Validation of a wearable device for measuring blood pressure without a cuff
Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
This study is testing a new wearable device that measures blood pressure without a cuff to see if it works as well as traditional blood pressure monitors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Perin Health Devices Industry-sponsored |
| Locations | 1 site (Woodland Hills, California) |
| Trial ID | NCT06574113 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the accuracy of a cuffless blood pressure measurement algorithm using the Perin Health Patch, a wearable device. It will compare the device's performance against traditional ambulatory blood pressure cuffs in 85 adult subjects over a 10-minute monitoring period. Participants may also undergo a cold pressor test followed by an additional monitoring period to assess the device's reliability under stress. The goal is to ensure that the measurements from the wearable device meet established performance standards.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who can provide informed consent and comply with study procedures.
Not a fit: Patients who are pregnant, children, have a pacemaker, or have a history of reactions to medical adhesives may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a more convenient and comfortable method for patients to monitor their blood pressure.
How similar studies have performed: Other studies have shown promise in validating wearable devices for blood pressure monitoring, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Woodland Hills, California
- Perin Health Devices — Woodland Hills, California, United States (Recruiting)
Study contacts
- Principal investigator: Ian M McLane, Ph.D. — Perin Health Devices
- Study coordinator: Ian M McLane, Ph.D.
- Email: imclane@phasemargin.com
- Phone: 8186069389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.