CTRI

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CTRI Number

CTRI/2025/09/094627 [Registered on: 11/09/2025] Trial Registered Prospectively

Last Modified On:

07/05/2026

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Single Arm Study

Public Title of Study

Dozees validation study for vitals, motion and bed exits

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Pradep Kumar Nagaraj
Designation	Consultant
Affiliation	Kanva Sri Sai Hospital
Address	227 Nandini Layout Main Rd Rajivgandhi Nagar Police Quarters Krishnananda Nagar Nandini Layout Bangalore KARNATAKA 560096 India
Phone	9449549307
Fax
Email	stalinpradeep@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Kumar Chokalingam
Designation	Head Clinical Research
Affiliation	Turtle Shell Technologies Pvt Ltd
Address	Nomads Daily Huddle City Centre 40 Chinmaya Mission Hospital Rd Stage 2 Bangalore KARNATAKA 560038 India
Phone	9008349922
Fax
Email	kumar.chokalingam@dozee.io

Details of Contact Person
Public Query

Name	Dr Kumar Chokalingam
Designation	Head Clinical Research
Affiliation	Turtle Shell Technologies Pvt Ltd
Address	Nomads Daily Huddle City Centre 40 Chinmaya Mission Hospital Rd Stage 2 Bangalore KARNATAKA 560038 India
Phone	9008349922
Fax
Email	kumar.chokalingam@dozee.io

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Turtle Shell Technologies Pvt Ltd
Address	Ground Mezzanine floor Nomads Daily Huddle City Centre 40 Chinmaya Mission Hospital Road Stage 2 Hoysala Nagar Indiranagar Bengaluru Karnataka 560008
Type of Sponsor	Other [Medical Device Company]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Pradep Kumar Nagaraj	Kanva Sri Sai Hospital	227 Nandini Layout Main Rd Rajivgandhi Nagar Police Quarters Krishnananda Nagar Nandini Layout Bangalore KARNATAKA	9449549307 stalinpradeep@gmail.com
Dr Pradep Kumar Nagaraj	Q Medical Center and Hospital	Q Medical Center(Speciality Hospital 43 Dickenson Rd next to Hasanath College Halasuru Hanumanthappa Layout Sivanchetti Gardens Bangalore KARNATAKA	09449549307 stalinpradeep@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 2
Name of Committee	Approval Status
ACE Independent Ethics Committee	Approved
ACE Independent Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: 4\|\|Measurement and Monitoring,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

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

Secondary Outcome

Outcome	TimePoints
To assess the agreement between Dozee and the gold standard reference device using Bland-Altman analysis for HR and RR.	At base line.
To evaluate the correlation between Dozee and the reference device using Deming regression and Pearson’s correlation coefficient for HR and RR.	At base line.
To determine the detection rate and range of HR and RR measured by Dozee.	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.	At base line.

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

12/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The objective of the present study is to validate the updated (Gen 2) HR and RR algorithms of the Dozee system. The study will focus on evaluating algorithm performance in the

intended use population, including validation across the three sensor sheet variants—the DS, S1 and S1-I—to confirm that these meet the clinical claims and expectations..