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Cuffless wrist gadget aims to simplify blood pressure checks

NCT ID NCT04027777

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a wrist-worn device that uses light to measure blood pressure without a traditional arm cuff. Researchers will compare its readings to standard blood pressure measurements in 355 adults over four weeks. The goal is to see if this optical method is accurate enough for everyday use.

What this could mean

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

Active substance
Aktiia optical blood pressure monitoring (OBPM) device
What this could lead to
If successful, this could provide a convenient, cuffless way to monitor blood pressure continuously at home.
What could go wrong
This is an early validation study, not a treatment trial. The device may not be as accurate as standard methods, and results may not apply to people with certain health conditions.

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 355 people

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

Started

Aug 2019

Expected to finish

Dec 2027

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

21 to 85 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.

ARM1 Inclusion Criteria: * Adult subjects (aged between 21 and 65 years old) * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects that have signed the informed consent form Exclusion Criteria: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects with hyper-/hypothyroidism * Subjects with pheochromocytoma * Subjects with Raynaud's disease * Subjects with trembling and shivering * Subjects with interarm systolic difference \> 15 mmHg * Subjects with interarm diastolic difference \> 10 mmHg * Subjects with arm paralysis * Women in known pregnancy * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 22 cm (limitation due Aktiia.bracelet-P0 size) * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases (limitation due to participant discomfort) * Subjects with lymphoedema (limitation due to participant discomfort) ARM2 Inclusion Criteria: * Adult subjects (aged between 21 and 65 years old) * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects that have signed the informed consent form Exclusion Criteria: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with hyper-/hypothyroidism * Subjects with pheochromocytoma * Subjects with Raynaud's disease * Subjects with trembling and shivering * Subjects with interarm systolic difference \> 15 mmHg * Subjects with interarm diastolic difference \> 10 mmHg * Subjects with arm paralysis * Women in known pregnancy * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 22 cm (limitation due Aktiia.bracelet-P0 size) * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases (limitation due to participant discomfort) * Subjects with lymphoedema (limitation due to participant discomfort) ARM3 Inclusion Criteria: * Adult subjects (aged between 65 and 85 years old) * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects that have signed the informed consent form Exclusion Criteria: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects with hyper-/hypothyroidism * Subjects with pheochromocytoma * Subjects with Raynaud's disease * Subjects with trembling and shivering * Subjects with interarm systolic difference \> 15 mmHg * Subjects with interarm diastolic difference \> 10 mmHg * Subjects with arm paralysis * Women in known pregnancy * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 22 cm (limitation due Aktiia.bracelet-P0 size) * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases (limitation due to participant discomfort) * Subjects with lymphoedema (limitation due to participant discomfort) ARM 4 The study arm will include: * Adult subjects aged between 21 and 85 years old * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site * Subjects able to pedal with an ergocycle * Subjects that have signed the informed consent form The study will exclude: * Subjects undergoing dialysis treatment * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with untreated hyper-/hypothyroidism * Subjects with pheochromocytoma * Subjects with Raynaud's disease * Subjects with trembling and shivering * Subjects with interarm systolic difference \> 15 mmHg * Subjects with interarm diastolic difference \> 10 mmHg * Subjects with arm paralysis * Women in known pregnancy * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema ARM 5 The study arm will include: * Adult subjects aged between 21 and 85 years old * Subjects with chronic systolic heart failure (Heart Failure with reduce Ejection Fraction), defined by a left ventricular ejection fraction (LVEF) of less than or equal to 40%, confirmed by Echocardiography or MRI * Subjects fluent in written and spoken French Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site * Subjects able to pedal with an ergocycle * Subjects that have signed the informed consent form The study will exclude: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects with untreated hyper-/hypothyroidism * Subjects with pheochromocytoma * Subjects with Raynaud's disease * Subjects with trembling and shivering * Subjects with interarm systolic difference \> 15 mmHg * Subjects with interarm diastolic difference \> 10 mmHg * Subjects with arm paralysis * Women in known pregnancy * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema ARM 6 The study arm will include: * Subjects who are adult females aged 21 years or older * Subjects who are pregnant beyond the first trimester, with a gestational age of more than 12 weeks, confirmed by documentation from a gynecologist * Subjects not requiring hospitalization * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site. * Subjects that have signed the informed consent form The study will exclude: * Subjects with tachycardia (heart rate at rest \> 120bpm * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects with untreated hyper/hypotyroidism not related to pregnancy changes * Subjects with pheochromocytoma * Subjects with Raynaud's disease * Subjects with trembling and shivering * Subjects with interarm systolic difference \> 15 mmHg * Subjects with interarm diastolic difference \> 10 mmHg * Subjects with arm paralysis * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema ARM 7 The study arm will include: * Subjects who are adult females aged 21 years or older * Subjects who are postpartum, defined as having given birth within the last 6 weeks and not currently pregnant * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site. * Subjects that have signed the informed consent form The study will exclude: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects with untreated hyper-/hypothyroidism * Subjects with pheochromocytoma * Subjects with Raynaud's disease * Subjects with trembling and shivering * Subjects with interarm systolic difference \> 15 mmHg * Subjects with interarm diastolic difference \> 10 mmHg * Subjects with arm paralysis * Women in known pregnancy * Subjects with an arteriovenous fistula * Subjects with arm amputations Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

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Contacts and locations

Locations

  • University of Lausanne Hospitals

    RECRUITING

    Lausanne, 1011, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.