Optical Blood Pressure Monitoring Via Mobile Application, 3 Arms Swiss Clinical Study

A study testing Blood pressure measurement in people with Blood Pressure, run by Biospectal at 2 sites in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Validation of an existing algorithm designed to estimate blood pressure based on collected optical signals on patients against two reference methods, which are the arterial catheter (arm 1) and the ausculatory sphygmomanometer (arm 2). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Blood Pressure
What is being tested?: Blood pressure measurement
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 350 participants
Where: 2 sitesSwitzerland
Study dates: 18 Mar 2019to 14 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Arm 1, Inclusion Criteria:

Informed Consent as documented by signature
Men or women older than 18 years old
Good understanding of written and oral speaking used at the centre where the study will be carried out
American Society of Anesthesiology clinical classification Risk (ASA) Class 1-3
Scheduled for a general anesthesia
Necessitating an arterial catheters for the anesthesia and surgery.

Arm 1, Exclusion Criteria:

Patients that cannot sign informed consent
Patients in emergency situation, are not legally competent, cannot understand the situation
ASA Risk class 4
Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
Known contact dermatitis to nickel/chromium

Arm 2, Inclusion Criteria:

Informed Consent as documented by signature
Men or women older than 18 years old
Good understanding of written and oral speaking used at the centre where the study will be carried out

Arm 2,Exclusion Criteria:

Patients that cannot sign informed consent
Patients in emergency situation, are not legally competent, cannot understand the situation
Known or suspected non-compliance (e.g. drug or alcohol abuse, language problems, psychological disorders, dementia)
Known pregnancy
Systolic blood pressure difference between two arms >15mmHg or, diastolic blood pressure difference between two arms >10mmHg
Unstable cardiac condition (myocardial infarction < 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
Dysrhythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
Known contact dermatitis to nickel/chromium.

Arm 3, Inclusion Criteria:

Informed Consent as documented by signature
Pregnant women older than 18 years old
Good understanding of written and oral speaking used at the centre where the study will be carried out
Scheduled for a prepartum anesthesia consultation at the hospital maternity unit

Arm 3,Exclusion Criteria:

Patients that cannot sign informed consent
Patients in emergency situation, are not legally competent, cannot understand the situation
Known or suspected non-compliance (e.g. drug or alcohol abuse, language problems, psychological disorders, dementia)
Systolic blood pressure difference between two arms >15mmHg or, diastolic blood pressure difference between two arms >10mmHg
Unstable cardiac condition (myocardial infarction < 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
Dysrhythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
Known contact dermatitis to nickel/chromium.

Trial locations and contacts

2 sites in 1 country.

Patrick Schoettker contact

‭+41 79 556 10 43

Patrick.Schoettker@chuv.ch

Switzerland2 sites, 1 recruiting

Hôpital Universitaire de Genève (HUG)
Geneva, 1205
Completed
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Patrick Schoettker, Patrick.Schoettker@chuv.ch
Patrick Schoettker
Recruiting

Other trials in Switzerland

About this study

Official title: Arm 1: Optical Blood Pressure Monitoring (OptiBP Mobile App), An Accurate Blood Pressure Measurement Compared to Invasive Blood Pressure Measurement. Arm 2 and Arm 3: Improvement and Validation of the Smartphone Blood Pressure Measurement (OptiBP Mobile App). A Prospective, Method Comparison, Proof of Concept Study in a Swiss Population.

Read the detailed description

The purpose of the study is to compare the blood pressure values measured by a mobile application used with a smartphone and the values measured by reference equipments, which are the arterial line and the ausculatory sphygmomanometer .

In the arm 1 of the study, patients scheduled for general anesthesia at the Centre Hospitalier Universitaire Vaudois (CHUV) and at the Hôpitaux Universitaire de Genève (HUG) will be recruited and their pressure will be measured with both mesurement methods. General anesthesia is known to generate significant variations in blood pressure at the time of induction. During the first minutes of anesthesia, the patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment. After the intervention, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.

In the arm 2, patients scheduled for a medical appointment at the hypertension unit of the Centre Hospitalier Universitaire Vaudois (CHUV) will be recruited. Their pressure will be measured with the mobile application and with the reference equipment at various time points. After the intervention, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.

In the arm 3, patients scheduled for a medical appointment at the maternity unit of the Centre Hospitalier Universitaire Vaudois (CHUV) will be recruited. Their pressure will be measured with the mobile application and with the reference equipment at various time points. After the intervention, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.

Conditions: Blood Pressure
Being tested: Blood pressure measurement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood pressure measurementDevice
Measure optically the blood pressure through the use of a smartphone

Study groups in NCT03875248
Study group	Role	What they receive
Arm 1. Blood pressure measurement compared to arterial line	Other	Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line). Receives: Device: Blood pressure measurement
Arm 2. Blood pressure measurement compared to manual cuff	Other	Comparative blood pressure measurement in hypertensive patients with the investigational device and the non-invasive reference method (manual cuff). Receives: Device: Blood pressure measurement
Arm 3. Blood pressure measurement compared to manual cuff	Other	Comparative blood pressure measurement in pregnant women with the investigational device and the non-invasive reference method (manual cuff). Receives: Device: Blood pressure measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

Confirmation of measurement done with the investigational device
Arm 1: Comparision of values to invasive reference method (arterial line)
Measured: First 20 minutes
Confirmation of measurement done with the investigational device
Arm 2: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)
Measured: First 20 minutes
Confirmation of measurement done with the investigational device
Arm 3: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)
Measured: First 20 minutes

Secondary outcomes (2)

Usability assessment
Identification of possible use error in the manipulation of the device and in the performance of the measure
Measured: First 20 minutes
Safety of procedure by assessing inconvenience and adverse events
Safety by assessing inconvenience and adverse events.
Measured: First 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 201914 Jun 2021

First posted14 Mar 2019
Study start18 Mar 2019
Primary completion14 Jun 2021 (estimated)
Study completion14 Jun 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Model description: The arm 1 of the study has been designed as a multicentric prospective pilot study. The arm 2 of the study has been designed as a monocentric prospective pilot study. The arm 3 of the study has been designed as a monocentric prospective pilot study.
Masking: None (open label)
Enrolment: 350 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03875248
Sponsor's protocol ID: BSP 2018/01
Acronym: OPTIBP
Status last verified: Jun 2020
First submitted: 13 Mar 2019
Last updated: 23 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Almeida P, Cuenoud A, Hoang H, Othenin-Girard A, Salhi N, Kothe A, Christen U, Schoettker P. Accuracy of the smartphone blood pressure measurement solution OptiBP to track blood pressure changes in pregnant women. J Hypertens. 2025 Apr 1;43(4):665-672. doi: 10.1097/HJH.0000000000003956. Epub 2025 Feb 7.
PubMed 39927734
Degott J, Ghajarzadeh-Wurzner A, Hofmann G, Proenca M, Bonnier G, Lemkaddem A, Lemay M, Christen U, Knebel JF, Durgnat V, Burnier M, Wuerzner G, Schoettker P. Smartphone based blood pressure measurement: accuracy of the OptiBP mobile application according to the AAMI/ESH/ISO universal validation protocol. Blood Press Monit. 2021 Dec 1;26(6):441-448. doi: 10.1097/MBP.0000000000000556.
PubMed 34139747

Want to know more?

Patrick Schoettker

‭+41 79 556 10 43

Patrick.Schoettker@chuv.ch

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Arm 1: Optical Blood Pressure Monitoring (OptiBP Mobile App), An Accurate Blood Pressure Measurement Compared to Invasive Blood Pressure Measurement. Arm 2 and Arm 3: Improvement and Validation of the Smartphone Blood Pressure Measurement (OptiBP Mobile App). A Prospective, Method Comparison, Proof of Concept Study in a Swiss Population.
ClinicalTrials.gov ID: NCT03875248
Acronym / sponsor ID: OPTIBP / BSP 2018/01
Conditions: Blood Pressure
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 350 participants (estimated)
Lead sponsor: BiospectalIndustry (pharma, biotech, devices)
Collaborators: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Study start: 18 Mar 2019 (actual)
Primary completion: 14 Jun 2021 (estimated)
Study completion: 14 Jun 2021 (estimated)
First posted: 14 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3
Model description: The arm 1 of the study has been designed as a multicentric prospective pilot study. The arm 2 of the study has been designed as a monocentric prospective pilot study. The arm 3 of the study has been designed as a monocentric prospective pilot study.

Arm	Type	Receives
Arm 1. Blood pressure measurement compared to arterial line	Other	Device: Blood pressure measurementComparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).
Arm 2. Blood pressure measurement compared to manual cuff	Other	Device: Blood pressure measurementComparative blood pressure measurement in hypertensive patients with the investigational device and the non-invasive reference method (manual cuff).
Arm 3. Blood pressure measurement compared to manual cuff	Other	Device: Blood pressure measurementComparative blood pressure measurement in pregnant women with the investigational device and the non-invasive reference method (manual cuff).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Blood pressure measurementMeasure optically the blood pressure through the use of a smartphone	Device	Arm 1. Blood pressure measurement compared to arterial line, Arm 2. Blood pressure measurement compared to manual cuff, Arm 3. Blood pressure measurement compared to manual cuff

Primary outcome

Confirmation of measurement done with the investigational device
Time frame: First 20 minutes
Arm 1: Comparision of values to invasive reference method (arterial line)
Confirmation of measurement done with the investigational device
Time frame: First 20 minutes
Arm 2: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)
Confirmation of measurement done with the investigational device
Time frame: First 20 minutes
Arm 3: Comparision of values to non-invasive reference method (ausculatory sphygmomanometer)

2 secondary outcomes

Usability assessment
Time frame: First 20 minutes
Safety of procedure by assessing inconvenience and adverse events
Time frame: First 20 minutes

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
Derived from this study: PubMed 39927734Almeida P, Cuenoud A, Hoang H, Othenin-Girard A, Salhi N, Kothe A, Christen U, Schoettker P. Accuracy of the smartphone blood pressure measurement solution OptiBP to track blood pressure changes in pregnant women. J Hypertens. 2025 Apr 1;43(4):665-672. doi: 10.1097/HJH.0000000000003956. Epub 2025 Feb 7.
Derived from this study: PubMed 34139747Degott J, Ghajarzadeh-Wurzner A, Hofmann G, Proenca M, Bonnier G, Lemkaddem A, Lemay M, Christen U, Knebel JF, Durgnat V, Burnier M, Wuerzner G, Schoettker P. Smartphone based blood pressure measurement: accuracy of the OptiBP mobile application according to the AAMI/ESH/ISO universal validation protocol. Blood Press Monit. 2021 Dec 1;26(6):441-448. doi: 10.1097/MBP.0000000000000556.
Individual participant dataSharing planned: No

Related trials for Blood Pressure

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick Schoettker contact

‭+41 79 556 10 43

Patrick.Schoettker@chuv.ch

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blood pressure measurement in people with Blood Pressure, run by Biospectal at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick Schoettker (‭+41 79 556 10 43, Patrick.Schoettker@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmation of measurement done with the investigational device (time frame: First 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03875248, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.