Could a pillow replace the blood pressure cuff?
NCT ID NCT07635602
First seen Jun 25, 2026 · Last updated Aug 05, 2026 · Updated 3 times
Summary
This study collected blood pressure data from 40 volunteers aged 40-80 using a special pillow-like device placed on the wrist. The device uses sensors to estimate blood pressure and the data was compared to readings from an invasive arterial line. The goal was to gather information to help develop a new algorithm for easier, non-invasive blood pressure monitoring.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a comfortable, pillow-based device for continuous blood pressure monitoring without the need for invasive arterial lines.
- What could go wrong
- This is a small, early-stage data collection study (40 people) focused on algorithm development, not on testing a finished device. The results may not translate to accurate blood pressure readings in real-world settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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50 people
The number who actually took part.
- Started
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Feb 2026
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 20-80 years old. * Ability and willingness to sign and understand an informed consent form. * The participant has a palpable radial pulse in both wrists. * The participant is willing and able to be fitted with the investigational device, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational device and A-line. * The participant was fitted with both CS BP Plate System devices (one for each hand) and CardiacSense technician has determined the measurement quality to be sufficient. Exclusion Criteria: * Participant who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the participant or interfere with the data collected. * Participant whose body habitus precludes them from wearing the investigational device on their wrists. * Female participants who self-reported as pregnant based on a urine pregnancy test, or who are self-reported as trying to get pregnant or who are breastfeeding. * Participant whose BMI is greater than 35. * Participant with a documented medical history of cardiac arrhythmia. * Participant with diagnosed diabetes mellitus. * Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal. * Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts. * Participant with pheochromocytoma or primary hyperaldosteronism. * Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke. * Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted). * Participant with an infection requiring antibiotics. * Participant with peripheral artery disease * Participants with compromised circulation, including Raynaud's syndrome. * Participant has a fracture, severe trauma, or anatomical deformity involving the wrist intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices. * Participant with moderate to severe valvulopathies. * Participant with primary vasculitis. * Participant with tremors or otherwise unable to remain still for 1 hour. * The left to right arm lateral difference of the average systolic blood pressure values is more than 15 mmHg or the lateral difference of the average diastolic blood pressure values is more than 10 mmHg.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Element Boulder Avista Adventist Hospital Plaza
Louisville, Colorado, 80027, United States
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