No Specific Medical Conditions or Disease StatesNCT05380102
Pilot Evaluation of an Continuous Contactless Vitals Parameter Monitoring System Dozee VS
An observational study of No Specific Medical Conditions or Disease States, run by Turtle Shell Technologies Pvt. Ltd. at 1 site in United States.
Trial summary
The Dozee VS device developed by Turtle Shell Technologies Pvt. Ltd., is a contactless continuous vital parameters monitoring system. It is designed for continuous and contactless measurement of Heart Rate (HR) and Respiratory Rate (RR). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- No Specific Medical Conditions or Disease States
- What is being tested?
- Telemetry monitoring, Continuous monitoring through Earlysense and Continuous monitoring through Dozee VS
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2022to 10 Jun 2022
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will be conducted on 105 subjects in the age group above 18 years regardless of gender. The patients admitted in the hospital will be informed about the study and a written informed consent form will be obtained from them. Dozee will be placed under the mattress of the patient's bed and the data will be collected through the device whenever a patient is on the bed. The research team members responsible for data analysis will have access only to the fully anonymised individual-level data and will be blinded to any other patient data, as well as to the components of the calculated scores in the hospital information system.
Who may be able to join
- Adults Male or female. (Above 18 years of age)
- Provide written informed consent.
- Weight between 40kg/88.18lbs and 120kg/264.55lbs(Above 40 kgs)
- Are located in a non-ICU hospital setting.
- Agree to not eat during the testing period (2hours or 10 hours accordingly)
Who cannot join
- Are connected to a device which may interfere with the device monitoring in this study.
- Are receiving any bedside care which may be incompatible with the study procedures.
- A likely need to receive or undergo a procedure during the testing period.
- Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
- Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastside Research Associates
Redmond, Washington, 98052
About this study
Official title: Pilot Clinical Evaluation of Dozee VS in Patients in Hospital Beds
The Dozee VS device developed by Turtle Shell Technologies Pvt. Ltd., is a contactless continuous vital parameters monitoring system. It is designed for continuous and contactless measurement of Heart Rate (HR) and Respiratory Rate (RR). The device uses the concept of ballistocardiography and deploys piezoelectric sensors to capture the micro-vibrations originating from cardiac contractions, upper respiratory tract activity and body movements. This data is then analyzed by a proprietary algorithm and the values of the vital parameters - Heart Rate (HR) and Respiratory Rate (RR) are generated. The captured vital parameters can be accessed remotely via a dashboard which can be accessed on any web browser and a smartphone application. The sensor sheet is placed below the mattress and captures data while the user is resting or sleeping and does not require a sensor to be fixed to the body. It consists of the following sub - units: Contactless sensor sheet, Dozee Pod with power cord, 5 Volt Universal Serial Bus (USB) Power Adapter, Health data compute server and Web Dashboard/Mobile App. This provides a more comfortable solution for long-term continuous patient monitoring. Continuous monitoring of people's vital signs, in particular Heart Rate (HR) and Respiratory Rate (RR), may provide a mechanism to alert doctors or nurses of clinical deterioration. Monitoring people's vital signs outside an ICU often relies on nursing staff conducting checks at set intervals. The device can reduce the workload for nursing staff in non-ICU wards.
Read the detailed description
Dozee VS device is intended for the contactless continuous monitoring of vital parameters (Heart Rate and Respiratory Rate), and screening for abnormal changes in these parameters. The device is intended to be used to monitor individuals/patients greater than eighteen (18) years of age (40 kg ≤ weight ≤ 120 kg) and can measure their vital signs during sleep and resting state. The data can be viewed on the dashboard, exported and even be directly transferred to the in-house hospital management software. This protocol aims at verifying the safety and effectiveness of the investigational device in a general-care clinical environment. A similar predicate can be found in the FDA-cleared EarlySense 2.0 (K131379) developed by EarlySense Limited which shall be used as the predicate device. The device also uses the concept of ballistocardiography and employs piezoelectric sensors to create a contact-less continuous monitoring system which monitors the same vital parameters. It has been sold in over 20 hospitals in United Sates, since 2013, with no recalls or adverse events reported. According to publicly available clinical results, this system has shown an 86% reduction in Code Blue events, and a 45% reduction in Length of Stay (LoS) in the Intensive Care Unit (ICU) for patients coming from the medical/surgical unit. The technology employed and the indications for use for the EarlySense device is very similar to the Dozee VS device.
- Being tested
- Telemetry monitoring, Continuous monitoring through Earlysense, Continuous monitoring through Dozee VS
- Keywords
- Continuous Monitoring, Ballistocardiography, HR, RR, Dozee VS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemetry monitoringDevice
All participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).
Continuous monitoring through EarlysenseDevice
EarlySense (USFDA approved ballistocardiography device) will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements
Continuous monitoring through Dozee VSDevice
Dozee VS will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study (Cohort) | All participants will be on standard telemetry monitoring for Heart Rate and Respiration Rate using the gold standard (Electrocardiography and Capnography respectively).
In addition, two contactless monitoring devices will be placed on the patient bed to measure data. These devices include EarlySense (USFDA approved ballistocardiography device) and Dozee VS (Investigational Device). Data from all devices will be measured simultaneously. Receives: Device: Telemetry monitoring; Device: Continuous monitoring through Earlysense; Device: Continuous monitoring through Dozee VS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Mean Square Difference (RMSD) of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate
Record heart rate in the investigational device and patient monitor at the same time every 60 seconds.
Calculate and compare the RMSD per patient and Bland-Alman plot of the heart rate for the investigational device and the gold standard device.
Measured: 12 Months
RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory Rate
Record respiratory rate in the investigational device and patient monitor at the same time every 60 seconds.
Calculate and compare the RMSD per patient and Bland-Alman plot of the respiratory rate for the investigational device and the gold standard device.
Measured: 12 Months
RMSD of Predicate Device's Heart Rate and Gold Standard Device's Heart Rate
Record heart rate in the predicate device and patient monitor at the same time every 60 seconds.
Calculate and compare the RMSD per patient and Bland-Alman plot of the heart rate for the predicate device and the gold standard device.
Measured: 12 Months
RMSD of Predicate Device's Respiratory Rate and Gold Standard Device's Respiratory Rate
Record respiratory rate in the investigational device and patient monitor at the same time every 60 seconds.
Calculate and compare the RMSD per patient and Bland-Alman plot of the respiratory rate for the predicate device and the gold standard device.
Measured: 12 Months
Secondary outcomes (4)
Motion Notification Accuracy - Device Under Investigation (DUI) (%)
Record the time for each instructed movements from manual observation and time for movements notification recorded in the investigational device.
Calculate the times matched between these two to get the accuracy.
Measured: 12 Months
Bed Exit Notification Accuracy - DUI (%)
Record the time for each instructed bed exit from manual observation and time for bed exit notification recorded in the investigational device.
Calculate the times matched between these two to get the accuracy.
Measured: 12 months
Motion Notification Accuracy - Predicate (%)
Record the time for each instructed movements from manual observation and time for movements notification recorded in the predicate device.
Calculate the times matched between these two to get the accuracy.
Measured: 12 months
Bed Exit Notification Accuracy - Predicate (%)
Record the time for each instructed bed exit from manual observation and time for bed exit notification recorded in the predicate device.
Calculate the times matched between these two to get the accuracy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start28 Apr 2022
- Primary completion3 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Specific Medical Conditions or Disease StatesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turtle Shell Technologies Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eastside Research Associates, HealthMinds
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380102
- Sponsor's protocol ID
- DOZ-22-001
- Other IDs
- 20221665
- Status last verified
- Jul 2022
- First submitted
- 11 May 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual Participant Data (IPD) are protected under HIPPA Act of 1996.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Evaluation of Dozee VS in Patients in Hospital Beds
- ClinicalTrials.gov ID
- NCT05380102
- Acronym / sponsor ID
- DOZ-22-001
- Keywords
- Continuous Monitoring, Ballistocardiography, HR, RR, Dozee VS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Turtle Shell Technologies Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Eastside Research Associates, HealthMinds
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 18 May 2022 (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.
The Dozee VS device developed by Turtle Shell Technologies Pvt. Ltd., is a contactless continuous vital parameters monitoring system. It is designed for continuous and contactless measurement of Heart Rate (HR) and Respiratory Rate (RR). The device uses the concept of ballistocardiography and deploys piezoelectric sensors to capture the micro-vibrations originating from cardiac contractions, upper respiratory tract activity and body movements. This data is then analyzed by a proprietary algorithm and the values of the vital parameters - Heart Rate (HR) and Respiratory Rate (RR) are generated. The captured vital parameters can be accessed remotely via a dashboard which can be accessed on any web browser and a smartphone application. The sensor sheet is placed below the mattress and captures data while the user is resting or sleeping and does not require a sensor to be fixed to the body. It consists of the following sub - units: Contactless sensor sheet, Dozee Pod with power cord, 5 Volt Universal Serial Bus (USB) Power Adapter, Health data compute server and Web Dashboard/Mobile App. This provides a more comfortable solution for long-term continuous patient monitoring. Continuous monitoring of people's vital signs, in particular Heart Rate (HR) and Respiratory Rate (RR), may provide a mechanism to alert doctors or nurses of clinical deterioration. Monitoring people's vital signs outside an ICU often relies on nursing staff conducting checks at set intervals. The device can reduce the workload for nursing staff in non-ICU wards.
Detailed description
Dozee VS device is intended for the contactless continuous monitoring of vital parameters (Heart Rate and Respiratory Rate), and screening for abnormal changes in these parameters. The device is intended to be used to monitor individuals/patients greater than eighteen (18) years of age (40 kg ≤ weight ≤ 120 kg) and can measure their vital signs during sleep and resting state. The data can be viewed on the dashboard, exported and even be directly transferred to the in-house hospital management software. This protocol aims at verifying the safety and effectiveness of the investigational device in a general-care clinical environment. A similar predicate can be found in the FDA-cleared EarlySense 2.0 (K131379) developed by EarlySense Limited which shall be used as the predicate device. The device also uses the concept of ballistocardiography and employs piezoelectric sensors to create a contact-less continuous monitoring system which monitors the same vital parameters. It has been sold in over 20 hospitals in United Sates, since 2013, with no recalls or adverse events reported. According to publicly available clinical results, this system has shown an 86% reduction in Code Blue events, and a 45% reduction in Length of Stay (LoS) in the Intensive Care Unit (ICU) for patients coming from the medical/surgical unit. The technology employed and the indications for use for the EarlySense device is very similar to the Dozee VS device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study (Cohort) | – | Device: Telemetry monitoring, Device: Continuous monitoring through Earlysense, Device: Continuous monitoring through Dozee VSAll participants will be on standard telemetry monitoring for Heart Rate and Respiration Rate using the gold standard (Electrocardiography and Capnography respectively). In addition, two contactless monitoring devices will be placed on the patient bed to measure data. These devices include EarlySense (USFDA approved ballistocardiography device) and Dozee VS (Investigational Device). Data from all devices will be measured simultaneously. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted on 105 subjects in the age group above 18 years regardless of gender. The patients admitted in the hospital will be informed about the study and a written informed consent form will be obtained from them. Dozee will be placed under the mattress of the patient's bed and the data will be collected through the device whenever a patient is on the bed. The research team members responsible for data analysis will have access only to the fully anonymised individual-level data and will be blinded to any other patient data, as well as to the components of the calculated scores in the hospital information system.
Key inclusion criteria (5 listed)
- Adults Male or female. (Above 18 years of age)
- Provide written informed consent.
- Weight between 40kg/88.18lbs and 120kg/264.55lbs(Above 40 kgs)
- Are located in a non-ICU hospital setting.
- Agree to not eat during the testing period (2hours or 10 hours accordingly)
Key exclusion criteria (6 listed)
- Are connected to a device which may interfere with the device monitoring in this study.
- Are receiving any bedside care which may be incompatible with the study procedures.
- A likely need to receive or undergo a procedure during the testing period.
- Cannot accept a nasal cannula, or have a monitor lead placed on the chest.
- Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.
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 |
|---|---|---|
| Telemetry monitoringAll participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively). | Device | Single Arm Study (Cohort) |
| Continuous monitoring through EarlysenseEarlySense (USFDA approved ballistocardiography device) will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements | Device | Single Arm Study (Cohort) |
| Continuous monitoring through Dozee VSDozee VS will be placed under the patients mattress to measure Heart Rate, Respiratory Rate and movements | Device | Single Arm Study (Cohort) |
Primary outcome
Root Mean Square Difference (RMSD) of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate
Time frame: 12 Months
Record heart rate in the investigational device and patient monitor at the same time every 60 seconds. Calculate and compare the RMSD per patient and Bland-Alman plot of the heart rate for the investigational device and the gold standard device.
RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory Rate
Time frame: 12 Months
Record respiratory rate in the investigational device and patient monitor at the same time every 60 seconds. Calculate and compare the RMSD per patient and Bland-Alman plot of the respiratory rate for the investigational device and the gold standard device.
RMSD of Predicate Device's Heart Rate and Gold Standard Device's Heart Rate
Time frame: 12 Months
Record heart rate in the predicate device and patient monitor at the same time every 60 seconds. Calculate and compare the RMSD per patient and Bland-Alman plot of the heart rate for the predicate device and the gold standard device.
RMSD of Predicate Device's Respiratory Rate and Gold Standard Device's Respiratory Rate
Time frame: 12 Months
Record respiratory rate in the investigational device and patient monitor at the same time every 60 seconds. Calculate and compare the RMSD per patient and Bland-Alman plot of the respiratory rate for the predicate device and the gold standard device.
4 secondary outcomes
Motion Notification Accuracy - Device Under Investigation (DUI) (%)
Time frame: 12 Months
Bed Exit Notification Accuracy - DUI (%)
Time frame: 12 months
Motion Notification Accuracy - Predicate (%)
Time frame: 12 months
Bed Exit Notification Accuracy - Predicate (%)
Time frame: 12 months
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 22 Jul 2022.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) are protected under HIPPA Act of 1996.
Related trials for No Specific Medical Conditions or Disease States
RecruitingObservational study
Dozee Validation for Contactless Heart Rate and Respiration Monitoring in Clinical Settings
No Specific Medical Conditions or Disease States
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 No Specific Medical Conditions or Disease States, run by Turtle Shell Technologies Pvt. Ltd. at 1 site in United States.
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 5 inclusion and 6 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 22 Jul 2022. 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 United States. 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?
Root Mean Square Difference (RMSD) of Investigational Device's Heart Rate and Gold Standard Device's Heart Rate (time frame: 12 Months). 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 22 Jul 2022.