Can a wristband replace the blood pressure cuff?
NCT ID NCT05780710
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new optical blood pressure monitor worn on the wrist to the standard arm cuff for home use. About 35 adults with high blood pressure (stage 1 or 2) will use both devices while taking medication. The goal is to see if the wrist monitor is as accurate and easy to use for managing blood pressure.
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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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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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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21 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: 1. Adult subjects aged 21 to 85 years old 2. Subjects that can read and speak French 3. Subjects that own a smart phone that uses either the iOS or Android operating system 4. Hypertensive Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) or Hypertensive Stage 2 (SBP 160-179 mmHg or DBP 100-109 mmHg) or for subjects aged \> 65yo SBP ≥160 mmHg, 5. Naive of antihypertensive drugs at the inclusion in the study (no antihypertensive drugs taken in the last 3 months before Visit 1) and during the conduct of the study apart from the study drugs 6. Subjects agreeing to attend all 4 on-site visits and follow study procedures 7. Subjects that have signed the informed consent form Exclusion Criteria: 1. Subjects have contraindications to the study drugs 2. Subjects with Hypertension Stage 3 (SBP/DBP \>180/110 mmHg) 3. Subjects with orthostatic hypotension (a 20 mmHg decrease in systolic BP, or 10 mmHg decrease in diastolic BP when measured in the standing position after a 1-minute waiting period) 4. Subjects who are likely to be unable to perform the HBPM required for the study within the designated time frame (7 to 11 a.m. and 4 to 9 p.m.). 5. Subjects having medical interventions or taking treatments during the study that could have an impact on their BP 6. For GROUPS 1 and 2 only: Subjects with target organ damage (left ventricular hypertrophy observed on ECG, and/ or, albumin/creatinine ratio in urine ≥3.5 mg/mmol) 7. Subjects with tachycardia (heart rate at rest \> 120bpm) 8. Subjects with atrial fibrillation 9. Cardio myopathy (FE\<40%) 10. Severe valvular disease 11. Implanted devices such as a pacemaker or defibrillator 12. Subjects with diabetes 13. Subjects with renal dysfunctions (eGFR \< 45mL/min/1.73 m2 for patients between 21-85 yo) 14. Subjects with hyper-/hypothyroidism 15. Subjects with pheochromocytoma 16. Subjects with Raynaud's disease 17. Subjects with an arteriovenous fistula 18. Women in known pregnancy 19. Subjects with trembling and shivering 20. Subjects with lymphoedema 21. Low or elevated potassium level: threshold ≤3.5 mmol/L or ≥4.8 mmol/L 22. Presence of an intravascular device 23. Subjects with exfoliative skin diseases 24. Subjects with arm paralysis 25. Subjects with arm amputation 26. Subjects with upper arm circumference \< 22cm or \> 42cm 27. Subjects with wrist circumference \> 23cm 28. Subjects with non-standard circadian rhythm, including shift workers and night workers 29. Subjects who have received a mastectomy.
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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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHUV
RECRUITINGLausanne, 1011, Switzerland
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CHVR
WITHDRAWNSion, Valais, 1951, Switzerland
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HUG
TERMINATEDGeneva, Canton of Geneva, 1205, Switzerland
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Other studies related to the condition(s) this trial covers.
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- Wristband vs. cuff: can a cuffless device match 24-Hour blood pressure monitoring?