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NCT05380102 · ClinicalTrials.gov registry record
Pilot Evaluation of an Continuous Contactless Vitals Parameter Monitoring System Dozee VS
A clinical trial, sponsored by Turtle Shell Technologies Pvt..
- Completed
- Registry status
- 51
- Enrollment target
NCT05380102: Completed study, sponsored by Turtle Shell Technologies Pvt..
NCT05380102 is a clinical trial that has completed, run by Turtle Shell Technologies Pvt.. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05380102 has completed, sponsored by Turtle Shell Technologies Pvt..
- COMPLETED
- Registry status
- 51 participants
- Enrollment target
Study 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). 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.
Primary Outcome
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.
Interventions
- DEVICE Telemetry monitoring
- DEVICE Continuous monitoring through Earlysense
- DEVICE Continuous monitoring through Dozee VS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2022-06-10 |
What the finished NCT05380102 record still lists
NCT05380102 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Telemetry monitoring is the first listed.
NCT05380102 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05380102 about?
NCT05380102 is a clinical study titled "Pilot Evaluation of an Continuous Contactless Vitals Parameter Monitoring System Dozee VS". 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 deploy...
What is the current status of trial NCT05380102?
This trial is currently completed. The enrollment target is 51 participants. The study started on 2022-04-28. Estimated completion is 2022-06-10.
What interventions are being tested in trial NCT05380102?
The interventions under investigation include: Telemetry monitoring (DEVICE), Continuous monitoring through Earlysense (DEVICE), Continuous monitoring through Dozee VS (DEVICE).
Who is sponsoring clinical trial NCT05380102?
This trial is sponsored by Turtle Shell Technologies Pvt., which has 4 total clinical trials registered on ClinicalTrials.gov.
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