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CTRI Number  CTRI/2024/08/071959 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 25/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Testing Dozee’s Contactless Vital Sign Measurements 
Scientific Title of Study   Clinical Validation of Dozee’s Contactless Vital Sign Measurements 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrYogesh Kothari 
Designation  Head of Cardiology 
Affiliation  Bhagwan Mahaveer Jain Hospital 
Address  Bhagwan Mahaveer Jain Hospital, Department of Cardiology, Second floor,Room No. 2205, Main building, Bangalore

Bangalore
KARNATAKA
560052
India 
Phone  9901973474  
Fax    
Email  dryogeshkothari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kumar Chokalingam 
Designation  Senior Clinical Research Manager 
Affiliation  Turtle Shell Technologies Pvt Ltd 
Address  40 City Centre Ground and Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd Indiranagar Bengaluru Karnataka

Bangalore
KARNATAKA
560038
India 
Phone  9008349922  
Fax    
Email  kumar.chokalingam@dozee.io  
 
Details of Contact Person
Public Query  
Name  Dr Kumar Chokalingam 
Designation  Senior Clinical Research Manager 
Affiliation  Turtle Shell Technologies Pvt Ltd 
Address  40 City Centre Ground and Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd Indiranagar Bengaluru Karnataka


KARNATAKA
560038
India 
Phone  9008349922  
Fax    
Email  kumar.chokalingam@dozee.io  
 
Source of Monetary or Material Support  
Turtle Shell Technologies Pvt Ltd City Centre 40 Ground and Mezzanine flr Nomads Daily Huddle Chinmaya Mission Hospital Rd Indiranagar Bengaluru Karnataka 560038 
 
Primary Sponsor  
Name  Turtle Shell Technologies Pvt Ltd 
Address  City Centre 40 Ground and Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd Indiranagar Bengaluru Karnataka 560038 
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrYogesh Kothari  Bhagwan Mahaveer jain Hospital  Cardiac Care Unit 3rd floor Bhagwan Mahaveer jain Hospital Vasanth Nagar Bangalore Karnataka 560052
Bangalore
KARNATAKA 		 9901973474

dryogeshkothari@gmail.com 
Dr Prashant Dhotre  Bhakti Vedanta Hospital and Research Institute  Sector 6 Sector 2 Srishti Complex Mira Road East Mira Bhayandar
Thane
MAHARASHTRA 		 9819082833

feasibility@bhaktivedantahospital.com 
Dr Aniruddha Jadav  MGM Medical College and Hospital  MGM campus, N-6, CIDCO, Chhatrapati Sambhaji Nagar (Aurangabad) - 43 1003
Aurangabad
MAHARASHTRA 		 7620286181

aniruddha.medexpress@gmail.com 
Jennifer  Panimalar Medical College Hospital and Research Institute  Varadharajapuram Chennai Outer Ring Road Poonamallee Chennai Banaveduthottam Tamil Nadu 600123
Chennai
TAMIL NADU 		 7305220021

ethosinpmchri@gmail.com 
Dr Laya Mahadevan  Saveetha Medical College and Hospital  SHIELD ICU, 3rd floor, Hospital builidng (General), Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai - 602105
Chennai
TAMIL NADU 		 9176646491

laya.luiz@gmail.com 
Dr Nishanth K R  Sri Jayadeva Institute of Cardiovascular Sciences and Research  ICU 5 2nd floor Infosis Building Jayanagar 9th Block Bannerghetta Road Bangalore
Bangalore
KARNATAKA 		 9880481530

kr.nishanth@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Bhakti Vedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
GeneBandhu Ethics Committee   Approved 
Mahatma Gandhi Missions Ethics Committee  Approved 
Panimalar Medicla College Hospital and Research Institute  Approved 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
SRI JAYADEVA 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  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Consenting adults 18 to 99 years ICU patients
They or legal representative are able and willing to provide written informed consent or have a legally authorized representative willing to provide written informed consent
For NcBP Patients already on radial ABP line or whose BP is measured using cuff BP
For RR Patients on continuous capnography monitoring
For HR patients on continuous ECG monitoring
Patients who have been screened for HR RR and or NcBP can be included for the data collection of SpO2 temperature and NiBP data. 
 
ExclusionCriteria 
Details  Currently pregnant
Exhibit injuries deformities or other abnormalities that in the opinion of the investigator, may prevent proper placement of accessories
Level of agitation or non-compliance too high to enroll
Needs the use of equipments whose operation can interfere with Dozee signal
A significant medical condition in the judgment of the investigator which may compromise the study testing procedures 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Mean Absolute Error (MAE) of Dozee NcBP across the range of each vitals
in comparison to gold standard 		 At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
MAE of Dozee RR in comparison to gold standard
MAE of Dozee HR in comparison to gold standard
MAE of Dozee NcBP RR and HR in comparison to gold standard across
different comorbidities
MAE of Dozee CE or and FDA approved contact based accessories
Bland-Altman analysis of the Dozee NcBP RR and HR in comparison to gold
standard
Deming Regression analysis and Pearson coefficient of the Dozee NcBP RR and HR in comparison to gold standard 		 Baseline 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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 most common parameters supervised by healthcare professionals to monitor patients’ health are heart rate (HR), respiration rate (RR), blood pressure (BP), oxygen saturation (SpO2), and temperature1

Conventional techniques for continuous monitoring of HR and RR rely on sophisticated equipment like multi-lead ECG sensors2 and nasal thermistors or nasal cannulas3. Continuous BP measurement typically involves intra-arterial BP monitoring (ABP), where a catheter is inserted into the artery for continuous BP monitoring4. However, ABP procedures are invasive and pose risks such as infection, bleeding, and thrombosis5. They are mainly restricted to Intensive Care Units (ICU) and are usually limited to critically ill patients, sometimes discontinued within a week due to discomfort and complications. For other hospitalized patients, periodic non-invasive cuff-based BP (NiBP) measurements are common, often done once a day. However, obtaining these readings can be difficult, disruptive (especially during sleep), and unreliable6,7. These traditional methods for HR, RR, and BP measurements are cumbersome and necessitate a high level of patient cooperation, as well as clinical expertise for accurate implementation.

Turtle Shell Technologies Pvt. Ltd. ’s (TST) Dozee system is a non-invasive continuous vitals monitoring system. The device employs piezoelectric sensors to capture micro-vibrations caused by cardiac contractions, upper respiratory tract activity, and body movements. It is based on the concept of ballistocardiography (BCG). The Dozee system is made up of non-contact sensor sheet(s) whose signals are used to calculate HR, RR, and non-contact blood pressure (NcBP). To measure temperature,  SpO2, and NiBP, contact accessories such as pulse oximeter, temperature probe, and cuff BP  respectively have been integrated.

This is a single-arm, unblinded, prospective, observational non-randomized study. The study will include 400 +ICU patients who provide consent. This study is considered an observational study as no Dozee data will be shared with clinical staff or the subject that may influence care. The study duration of enrolment for each patient will be 24hrs-72hrs.

  1. Dias D, Paulo Silva Cunha J. Wearable Health Devices-Vital Sign Monitoring, Systems and Technologies. Sensors (Basel). 2018 Jul 25;18(8):2414. doi: 10.3390/s18082414. PMID: 30044415; PMCID: PMC6111409.

  2. Sandau KE, et.al., American Heart Association Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Cardiovascular Disease in the Young. Update to Practice Standards for Electrocardiographic Monitoring in Hospital Settings: A Scientific Statement From the American Heart Association. Circulation. Nov 7;136(19):e273-e344.(2017)

  3. Subbe, Christian Peter & Kinsella, Sean. (2018). Continuous Monitoring of Respiratory Rate in Emergency Admissions: Evaluation of the RespiraSenseâ„¢ Sensor in Acute Care Compared to the Industry Standard and gold standard. Sensors. 18. 2700. 10.3390/s18082700. 

  4. Gravenstein J, Paulus D. Invasive Blood Pressure Monitoring. Clinical Monitoring in Practice. Philadelphia: JB Lippincott; 1987.

  5. Nguyen Y, Bora V. Arterial Pressure Monitoring. [Updated 2021 May 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK556127/

  6. Palatini P, Asmar R. Cuff challenges in blood pressure measurement. J Clin Hypertens (Greenwich). 2018 Jul;20(7):1100-1103. doi: 10.1111/jch.13301. PMID: 30003699; PMCID: PMC8030978.

  7. de Greeff A, Lorde I, Wilton A, Seed P, Coleman A, Shennan A. Calibration accuracy of hospital-based non-invasive blood pressure measuring devices. J Hum Hypertens. Jan 2010;24(1):58-63.

 
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