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Dozees validation study for vitals, motion and bed exits

Clinical Validation of the Dozee System for Contactless Monitoring of Heart Rate, Respiration Rate, Motion, and Bed-Exits - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/094627
Enrollment
100
Registered
2025-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Nil: Nil

Sponsors

Turtle Shell Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults Male or female. (Above 18 years of age) 2. Provide written informed consent. 3. Weight between 40kg/88.18lbs and 120kg/264.55lbs 4. Agree to not eat during the testing period 5. Able to move and exit the bed independently and safely.

Exclusion criteria

Exclusion criteria: 1. Are connected to a device that may interfere with the device monitoring in this study. 2. Are receiving any bedside care which may be incompatible with the study procedures. 3. A likely need to receive or undergo a procedure during the testing period. 4. Cannot accept a nasal cannula, or have an ECG leads placed on the chest. 5. Have a significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.

Design outcomes

Primary

MeasureTime frame
To evaluate whether the Dozee device meets the predefined product specifications for accuracy in measuring HR, RR, Motion and Bed-Exit.Timepoint: At base line.

Secondary

MeasureTime frame
To assess the agreement between Dozee and the gold standard reference device using Bland-Altman analysis for HR and RR.Timepoint: At base line.;To evaluate the correlation between Dozee and the reference device using Deming regression and Pearsonâ??s correlation coefficient for HR and RR.Timepoint: At base line.;To determine the detection rate and range of HR and RR measured by Dozee.Timepoint: At base line.;To benchmark the performance of the latest Dozee algorithm in comparison with other versions through retrospective analysis using the collected BCG data.Timepoint: At base line.

Countries

India

Contacts

Public ContactDr Kumar Chokalingam

Turtle Shell Technologies Pvt Ltd

kumar.chokalingam@dozee.io9008349922

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026