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Blood pressure without the cuff? a watch and pillow aim to track it

NCT ID NCT07749963

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This study gathers blood pressure data from healthy volunteers aged 50 to 80 using two experimental wearable devices: a wrist-worn watch and a pillow-like sensor placed over the wrist. The devices estimate blood pressure from heart and pulse signals, and their readings are compared with standard invasive and cuff-based measurements. The goal is to collect enough data to develop and refine the algorithms that power these non-invasive blood pressure monitors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CS BP Watch and CS BP Pillow Systems (non-invasive wearable devices that estimate blood pressure from heart and pulse signals)
What this could lead to
If successful, this could lead to a comfortable, non-invasive way to continuously monitor blood pressure using a watch or pillow, potentially improving hypertension management.
What could go wrong
This is an early data-collection study, not a test of a finished product. The devices may not accurately estimate blood pressure in all people, and further development and validation are needed.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

50 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Main Inclusion Criteria: 1. 50-80 years old. 2. Ability and willingness to sign and understand an informed consent form. 3. The participant has a palpable radial pulse in both wrists. 4. The participant is willing and able to be fitted with the investigational devices, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational devices and A-line. 5. Participant has good signal quality with the CS Pillow at both wrists. 6. Participant has good PPG signals in both thumbs. 7. Participant has good ECG signals using the Watch. Main Exclusion Criteria: 1. 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. 2. Participant who has previously participated in a BP study conducted by CardiacSense. 3. Participant whose body habitus precludes them from wearing the investigational devices. 4. 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. 5. Participant whose BMI is greater than 35. 6. Participant with a documented medical history of cardiac arrhythmia or if arrhythmia was detected during the screening. 7. Participant with diagnosed diabetes mellitus. 8. Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal. 9. Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts. 10. Participant with pheochromocytoma or primary hyperaldosteronism. 11. Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke. 12. Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted). 13. Participant with an infection requiring antibiotics. 14. Participant with autonomic dysfunction (such as orthostatic hypotension or neuropathy). 15. Participant with peripheral artery disease 16. Participants with compromised circulation, including Raynaud's syndrome. 17. Participant has a fracture, severe trauma, or anatomical deformity involving the wrist or fingers intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices. 18. Participant with moderate to severe valvulopathies. 19. Participant with primary vasculitis. 20. Participant with tremors or otherwise unable to remain still for 1 hour. 21. Participants with changes to their antihypertensive medication regimen, including initiation, discontinuation, or dose modification, within 30 days prior to enrollment. 22. 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. 23. Participant belongs to a recruitment category that has already been filled, including BMI category, height category, age group, sex, skin tone category, or blood pressure classification group. 24. Participant with contact allergy to ultrasound gel. 25. Participant with prior or known allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine). 26. Participant with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported). 27. Participant with other known health conditions, that might put the participant at risk or might jeopardize the quality of the data collected. 28. Participant that fails the modified Allen's test (Perfusion Index Ulnar/Ulnar+Radial Ratio test) (Ratio \< 0.4).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Element Boulder Avista Adventist Hospital Plaza

    RECRUITING

    Louisville, Colorado, 80027, United States

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