ArrhythmiaBedMonNCT03572751
Suitability of Unobtrusive Bed Monitoring and Wrist-worn Heart Rate Monitor for Patient Monitoring
An observational study of Arrhythmia and Hemorrhage, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Novel technology enables it to monitor noninvasively the vital signs of a patient. Such a monitoring is immediately required to improve patient safety and to reduce hospital readmissions. In this study, novel bed- and wearable sensors are studied for this purpose. Read more about this study
- Who is it for?
- Ages 50 to 120 years
- Conditions the study is for
- Arrhythmia, Hemorrhage, Septic Shock
- What is being tested?
- Bed-, wrist- and ECG-sensor monitoring
- How many people
- 36 participants
- Where
- 1 siteFinland
- Study dates
- 9 Apr 2018to 31 Dec 2018
- Phase
- Observational
- 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 50 to 120 years
- All sexes
- Adult, Older adult
Study population: Caucasian
Who may be able to join
- Age>50
- Indication for operation: peripheral arterial bypass and/or endarterectomy, aortic surgery, carotid surgery
- Volunteering
Who cannot join
- Pacemaker
- Denial
Trial locations and contacts
1 site in 1 country.
About this study
Novel technology enables it to monitor noninvasively the vital signs of a patient. Such a monitoring is immediately required to improve patient safety and to reduce hospital readmissions. In this study, novel bed- and wearable sensors are studied for this purpose.
Read the detailed description
Unobtrusive bed monitoring devices have gained popularity in the area of voluntary sleep quality monitoring for wellness purposes. Most of these devices rely on the measurement of ballistocardiographic forces caused by the acceleration of blood when the heart pumps it to aorta, forces caused by respiration movements and other movements of the person being monitored. A thin film-type force sensor placed under the bed mattress, between the matrices or under the bed sheet is often used for measuring these forces. While proven to provide adequate reliability and accuracy for wellness monitoring of healthy people, unobtrusive bed monitoring solutions have not yet been widely deployed in hospital patient monitoring even though there would be much use for such technology e.g. in regular hospital wards where currently the amount of patient monitoring is very limited.
If proven operational in this application, bed monitoring technology would provide tremendous benefits in both clinical and home monitoring scenarios. Wrist worn pulse plethysmography (PPG) devices have increased their popularity as heart rate monitors, referred as optical heart rate monitors (OHR) for sports and wellness in recent years and their ability to measure average heart rate during movement and beat-to-beat heart rate while at rest accurately with healthy people has been shown.
The objective of the study is to collect ECG and movement data measured with a wearable ECG monitor and simultaneously record data with unobtrusive bed sensor and wrist worn PPG device. Data recorded with the bed and wrist sensors and vital parameters calculated from that or provided by the monitoring devices directly will be compared with the reference.
The purpose of the study is to gain knowledge about the feasibility of unobtrusive bed and wrist monitoring devices for patient monitoring. The collected data will directly provide information on the accuracy of the current algorithms of the monitors. Besides this evaluation, the collected data will be used in developing new algorithms for detection of cardiac problems.
The study includes collection of data from vascular patients referred to surgical operation in Tampere University Hospital. Data collection takes place at vascular surgical ward where one dedicated research bed is equipped with bed monitoring devices. Another group of subjects is formed by healthy volunteers.
- Conditions
- Arrhythmia, Hemorrhage, Septic Shock, Consciousness, Loss of, Sleep
- Being tested
- Bed-, wrist- and ECG-sensor monitoring
- Keywords
- Sensor, Wearable
- Medical subject headings
- Arrhythmias, Cardiac, Hemorrhage, Shock, Septic, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed-, wrist- and ECG-sensor monitoringDiagnostic test
Bed-, wrist- and ECG-sensor monitoring
| Study group | Role | What they receive |
|---|---|---|
| Vascular surgical patients | Patient subjects are recruited from patients referred for vascular surgical procedure in Tampere University Hospital.
Bed-, wrist- and ECG-sensor monitoring Receives: Diagnostic Test: Bed-, wrist- and ECG-sensor monitoring | |
| Healthy volunteers | Healthy volunteer subjects will be recruited mainly from the students of Tampere University of Technology.
Bed-, wrist- and ECG-sensor monitoring Receives: Diagnostic Test: Bed-, wrist- and ECG-sensor monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and precision of heart rate (1/s) measurement by a bed sensor
Comparison of bed sensor derived heart rate with ECG reference to determine accuracy and precision of heart rate measurement by a bed sensor
Measured: 24 hours
Accuracy and precision of heart rate variability (ms) measurement by a bed sensor
Comparison of bed sensor derived heart rate variability with ECG reference
Measured: 24 hours
Accuracy and precision of respiratory rate (1/min) measurement by a bed sensor
Comparison of bed sensor derived respiratory rate measurement with accelerometer derived reference
Measured: 24 hours
Accuracy and precision of body movement detection
Comparison of bed sensor derived body movement with accelerometer derived reference
Measured: 24 hours
Secondary outcomes (3)
Duration of light sleep
Measurement of light sleep duration by bed-worn sensor
Measured: 24 hours
Duration of rapid eye movement (REM) sleep
Measurement of REM sleep duration by bed-worn sensor
Measured: 24 hours
Duration of deep sleep
Measurement of deep sleep duration by bed-worn sensor
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start9 Apr 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University of Technology, Tampere University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572751
- Sponsor's protocol ID
- R17027
- Acronym
- BedMon
- Status last verified
- Apr 2019
- First submitted
- 26 Mar 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suitability of Unobtrusive Bed Monitoring and Wrist-worn Heart Rate Monitor for Patient Monitoring
- ClinicalTrials.gov ID
- NCT03572751
- Acronym / sponsor ID
- BedMon / R17027
- Conditions
- Arrhythmia, Hemorrhage, Septic Shock, Consciousness, Loss of, Sleep
- Keywords
- Sensor, Wearable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University of Technology, Tampere University
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Jun 2018 (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.
Novel technology enables it to monitor noninvasively the vital signs of a patient. Such a monitoring is immediately required to improve patient safety and to reduce hospital readmissions. In this study, novel bed- and wearable sensors are studied for this purpose.
Detailed description
Unobtrusive bed monitoring devices have gained popularity in the area of voluntary sleep quality monitoring for wellness purposes. Most of these devices rely on the measurement of ballistocardiographic forces caused by the acceleration of blood when the heart pumps it to aorta, forces caused by respiration movements and other movements of the person being monitored. A thin film-type force sensor placed under the bed mattress, between the matrices or under the bed sheet is often used for measuring these forces. While proven to provide adequate reliability and accuracy for wellness monitoring of healthy people, unobtrusive bed monitoring solutions have not yet been widely deployed in hospital patient monitoring even though there would be much use for such technology e.g. in regular hospital wards where currently the amount of patient monitoring is very limited.
If proven operational in this application, bed monitoring technology would provide tremendous benefits in both clinical and home monitoring scenarios. Wrist worn pulse plethysmography (PPG) devices have increased their popularity as heart rate monitors, referred as optical heart rate monitors (OHR) for sports and wellness in recent years and their ability to measure average heart rate during movement and beat-to-beat heart rate while at rest accurately with healthy people has been shown.
The objective of the study is to collect ECG and movement data measured with a wearable ECG monitor and simultaneously record data with unobtrusive bed sensor and wrist worn PPG device. Data recorded with the bed and wrist sensors and vital parameters calculated from that or provided by the monitoring devices directly will be compared with the reference.
The purpose of the study is to gain knowledge about the feasibility of unobtrusive bed and wrist monitoring devices for patient monitoring. The collected data will directly provide information on the accuracy of the current algorithms of the monitors. Besides this evaluation, the collected data will be used in developing new algorithms for detection of cardiac problems.
The study includes collection of data from vascular patients referred to surgical operation in Tampere University Hospital. Data collection takes place at vascular surgical ward where one dedicated research bed is equipped with bed monitoring devices. Another group of subjects is formed by healthy volunteers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascular surgical patients | – | Diagnostic Test: Bed-, wrist- and ECG-sensor monitoringPatient subjects are recruited from patients referred for vascular surgical procedure in Tampere University Hospital. Bed-, wrist- and ECG-sensor monitoring |
| Healthy volunteers | – | Diagnostic Test: Bed-, wrist- and ECG-sensor monitoringHealthy volunteer subjects will be recruited mainly from the students of Tampere University of Technology. Bed-, wrist- and ECG-sensor monitoring |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Caucasian
Key inclusion criteria (3 listed)
- Age>50
- Indication for operation: peripheral arterial bypass and/or endarterectomy, aortic surgery, carotid surgery
- Volunteering
Key exclusion criteria (2 listed)
- Pacemaker
- Denial
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 |
|---|---|---|
| Bed-, wrist- and ECG-sensor monitoringBed-, wrist- and ECG-sensor monitoring | Diagnostic test | Healthy volunteers, Vascular surgical patients |
Primary outcome
Accuracy and precision of heart rate (1/s) measurement by a bed sensor
Time frame: 24 hours
Comparison of bed sensor derived heart rate with ECG reference to determine accuracy and precision of heart rate measurement by a bed sensor
Accuracy and precision of heart rate variability (ms) measurement by a bed sensor
Time frame: 24 hours
Comparison of bed sensor derived heart rate variability with ECG reference
Accuracy and precision of respiratory rate (1/min) measurement by a bed sensor
Time frame: 24 hours
Comparison of bed sensor derived respiratory rate measurement with accelerometer derived reference
Accuracy and precision of body movement detection
Time frame: 24 hours
Comparison of bed sensor derived body movement with accelerometer derived reference
3 secondary outcomes
Duration of light sleep
Time frame: 24 hours
Duration of rapid eye movement (REM) sleep
Time frame: 24 hours
Duration of deep sleep
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Hemorrhage, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and precision of heart rate (1/s) measurement by a bed sensor (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2019.