FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/05/087239 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   Dozee’s accuracy and reliability in different conditions 
Scientific Title of Study   Evaluation of the Accuracy and Reliability of the Dozee System for Vital Sign Monitoring in Diverse Conditions 
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 Kumar Chokalingam 
Designation  Head Clinical Research  
Affiliation  Turtle Shell Technologies Pvt Ltd 
Address  Department of Clinical Research #40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd, Indiranagar
Department of Clinical Research #40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd, Indiranagar
Bangalore
KARNATAKA
560038
India 
Phone  9008349922  
Fax    
Email  kumar.chokalingam@dozee.io  
 
Details of Contact Person
Scientific Query  
Name  Dr Abdul Khayum K 
Designation  Manager Clinical Research 
Affiliation  Turtle Shell Technologies Pvt Ltd 
Address  Department of Clinical Research #40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd, Indiranagar
Department of Clinical Research #40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd, Indiranagar
Bangalore
KARNATAKA
560038
India 
Phone  9600331252  
Fax    
Email  abdulkhayum@dozee.io  
 
Details of Contact Person
Public Query  
Name  Dr Abdul Khayum K 
Designation  Manager Clinical Research 
Affiliation  Turtle Shell Technologies Pvt Ltd 
Address  Department of Clinical Research #40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd, Indiranagar
Department of Clinical Research #40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd, Indiranagar
Bangalore
KARNATAKA
560038
India 
Phone  9600331252  
Fax    
Email  abdulkhayum@dozee.io  
 
Source of Monetary or Material Support  
Turtle Shell Technologies Pvt Ltd #40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Road Indiranagar Bangalore - 560038 Karnataka  
 
Primary Sponsor  
Name  Turtle Shell Technologies Pvt Ltd 
Address  #40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Road Indiranagar Bangalore - 560038 Karnataka 
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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Mahesh Appaji  B.M.S. College of Engineering  Bull Temple Road, Bangalore-560019, India
Bangalore
KARNATAKA 		 9844923632

abhishek.ml@bmsce.ac.in 
Dr Nishanth K R  Sri Jayadeva Institute of Cardiovascular Sciences and Research  Jayanagar 9th Block Bannerghetta Road BangaloreBangalore, KARNATAKA
Bangalore
KARNATAKA 		 9880481530

kr.nishanth@gmail.com 
Dr Kumar Chokalingam  Turtle Shell Technologies Pvt Ltd  Department of Clinical Research #40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Rd, Indiranagar
Bangalore
KARNATAKA 		 9008349922

kumar.chokalingam@dozee.io 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
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 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Consenting adults 18 years old ICU patients
2. Weight between 40kg-120kgs
3. They are able and willing to provide written informed consent or have a legally authorized representative willing to provide written informed consent 
 
ExclusionCriteria 
Details  1. Weight below 40 kgs and above 120 kgs
2. Currently pregnant
3. Exhibit injuries, deformities, or other abnormalities that, in the opinion of the
investigator, may prevent proper placement of accessories
4. Level of agitation or non-compliance too high to enroll
5. Needs the use of equipments whose operation can interfere with Dozee’s signal
6. A significant medical condition in the judgment 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 
1. Mean absolute Error (MAE) of Dozee’s vitals parameters, HR, HRV, RR, BP, Temperature and SpO2 in comparison with the gold standard and or
equivalent devices
2. Motion Notification Accuracy (%), Bed Exit Notification Accuracy and Posture Accuracy (%) of the Dozee in comparison with equivalent devices
and manual observations.
3. Dozee’s sensitivity in the detection of heart rhythms in comparison with the
gold standard method. 		 Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
Dozees detection rate and or detection range of HR HRV RR BP SpO2 cardiac rhythms in comparison to the gold standard and or equivalent devices  Baseline 
 
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)   02/06/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   This study is to validate the accuracy and reliability of the Dozee system in measuring vital parameters, including heart rate (HR), heart rate variability (HRV), respiratory rate (RR), temperature, oxygen saturation (SpO2), blood pressure (BP), heart rhythm, posture, and motion (movement accuracy and bed exit accuracy). This validation will be achieved by comparing the measurements obtained from the Dozee system to those from gold standard devices, equivalent devices operating on similar principles, and manual observations under diverse environmental and subject-specific conditions. 
Close