Validating Dozee for Contactless Monitoring of Heart, Breathing, and Movemen
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorTurtle Shell Technologies Pvt. Ltd.
About this trial
The Dozee VS system (K221555) is a contactless device that tracks heart rate and breathing rate using a sensor sheet placed under the mattress. It captures body vibrations and converts them into vital signs, which can be monitored remotely in real time. The system also supports add-ons like a blood pressure cuff, pulse oximeter, and thermometer, offering a complete monitoring solution. This study aims to validate the updated AI-powered heart rate and improved breathing rate algorithms across different sensor sheet types to confirm clinical accuracy
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults Male or female. (Above 18 years of age)
Provide written informed consent.
Weight between 40kg/88.18lbs and 120kg/264.55lbs
Agree to not eat during the testing period
Disqualifiers
Are connected to a device that 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 an ECG leads placed on the chest.
Trial population
The study will be conducted on atleast 60 subjects in the age group above 18 years regardless of gender. The patients/volunteers 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Device: Telemetry monitoring
DeviceAll participants will be on standard telemetry monitoring for Heart Rate, Respiration Rate and movements using the gold standard (Electrocardiography and Capnography respectively).
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Single Arm Study (Cohort)1 intervention
Trial outcomes
Primary outcomes
1
Mean Absolute Error (MAE) of Dozee's Heart Rate a from the Gold Standard ECG
Heart Rate collected at 1 Min intervals from gold standard and Dozee. Mean Absolute Error (MAE) of the Dozee Heart Rate will be calculated.
Time frame
6 months2
Accuracy (%) of Dozee in identfying subject movement
Time stamps of subject movement during the study will be recorded manullay. Time stamps of Dozee's movement will be recorded. Accuracy of the Dozee device in detecting movement compared to manual observation will be computed in terms of percentage.
Time frame
6 months3
Accuracy(%) of of Dozee's bed-exits
Time stamps of bed-exits will be recorded manually during the study will be recorded. Time stamps of Dozee's bed-exit will be computed. Accuracy of the Dozee device in detecting bed-exit compared to manual observation as gold standard will be computed in terms of percentage.
Time frame
6 months4
Mean Absolute Error (MAE) of Dozee's Respiratory Rate from the Gold Standard Capnography
Respiratory Rate collected at 1 Min intervals from gold standard and Dozee. Mean Absolute Error (MAE) of the Dozee Respiratory Rate will be calculated.
Time frame
6 MonthsSecondary outcomes
1
Range of values (minimum, maximum, and spread) of Heart Rate in beats per min measured by the gold standard and the Dozee
The outcome will be assessed by comparing the range of values (minimum, maximum, and spread) of Heart Rate ( beats per minute) measured by the gold standard and the Dozee over the study period.
Time frame
6 months2
Range of values (minimum, maximum, and spread) of Respiratory Rate in breaths per min measured by the gold standard and the Dozee
The outcome will be assessed by comparing the range of values (minimum, maximum, and spread) of Respiratory Rate ( breaths per minute) measured by the gold standard and the Dozee over the study period.
Time frame
6 Months3
Bland- Altman Level of Agreement between Dozee Heart Rate and Respiratory Rate with the Gold Standard
Level of Agreement between Dozee's HR and RR with reference device computed by Bland Altman.
Time frame
6 months4
Detection rate (%) of the Dozee's Heart Rate and Respiratory Rate
The time-stamps of Dozee's Heart Rate and Respiratory Rate and the gold standard Heart Rate and Respiratory Rate will be recorded. DR is the proportion of gold standard points for which the DS successfully provides a corresponding measured value, relative to the total number of gold standard points.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Turtle Shell Technologies Pvt. Ltd.
Lead sponsor
Eastside Research Associates
Collaborator
Source ClinicalTrials.gov