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CTRI Number  CTRI/2025/02/080139 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Comparison Study 
Study Design  Single Arm Study 
Public Title of Study   Detecting Breathing Patterns Using a contactless Ballistocardiography Device 
Scientific Title of Study   Assessment of Abnormal Respiratory Patterns Using a Non-Invasive Ballistocardiography Device 
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 Anindya Dasgupta 
Designation  Clinical Management and Insights Manager 
Affiliation  Turtle Shell Technologies Pvt Ltd 
Address  Ground and Mezanine flr Nomads Daily Huddle City center 40 Chinmaya Mission Hospital Rd Stage 2 Hoysala Nagar Indiranagar

Bangalore
KARNATAKA
560038
India 
Phone  9432672574  
Fax    
Email  anindya@dozee.io  
 
Details of Contact Person
Scientific Query  
Name  Dr Abdul Khayum K 
Designation  Clinical Research Manager 
Affiliation  Turtle Shell Technologies Pvt Ltd 
Address  Ground and Mezanine flr Nomads Daily Huddle City center 40 Chinmaya Mission Hospital Rd Stage 2 Hoysala Nagar Indiranagar

Bangalore
KARNATAKA
560038
India 
Phone  9600331252  
Fax    
Email  abdulkhayum@dozee.io  
 
Details of Contact Person
Public Query  
Name  Dr Abdul Khayum K 
Designation  Clinical Research Manager 
Affiliation  Turtle Shell Technologies Pvt Ltd 
Address  Ground and Mezanine flr Nomads Daily Huddle City center 40 Chinmaya Mission Hospital Rd Stage 2 Hoysala Nagar Indiranagar


KARNATAKA
560038
India 
Phone  9600331252  
Fax    
Email  abdulkhayum@dozee.io  
 
Source of Monetary or Material Support  
40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Road Indiranagar Bangalore Karnataka - 560038 
 
Primary Sponsor  
Name  Turtle Shell Technologies Pvt Ltd 
Address  40 City Centre Mezzanine Floor Nomads Daily Huddle Chinmaya Mission Hospital Road Indiranagar Bangalore Karnataka - 560038 
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 Anindya Dasgupta  NIMHANS  The Human Sleep Research Laboratory Department of Neurophysiology NIMHANS Lakkasandra Laljinagar Wilson Garden
Bangalore
KARNATAKA 		 9432672574

anindya@dozee.io 
Dr Anindya Dasgupta  Turtle Shell technologies Pvt Ltd  Ground and Mezanine flr Nomads Daily Huddle City center 40 Chinmaya Mission Hospital Rd Stage 2 Hoysala Nagar Indiranagar
Bangalore
KARNATAKA 		 9432672574

anindya@dozee.io 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GeneBandhu 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  65.00 Year(s)
Gender  Both 
Details  Consenting adults of age 18 to 65 years
Weight between 40kg to 120kg
Able to provide a written consent 
 
ExclusionCriteria 
Details  Weight below 40 kgs and above 120 kgs
Currently pregnant
Exhibit injuries deformities or other abnormalities that in the opinion of the
investigator may prevent proper placement of accessories
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    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Identification and characterization of "M-shaped" respiratory waveforms in
BCG signals across various controlled breathing scenarios.
Quantification of the frequency and consistency of "M-shaped" waveforms in
relation to specific respiratory patterns.
Statistical metrics describing waveform variability, including amplitude,
duration, and shape consistency. 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in waveform morphology, amplitude, and frequency during different
breathing patterns.
2. MAE between Dozee RR and reference RR across all scenarios.
3. MAE between Dozee HR and reference HR across all scenarios
4. Limits of agreement and bias observed in Bland-Altman plots.
5. Regression slope and intercept from Deming regression analysis.
6. Pearson correlation coefficient between Dozee RR and reference RR.
7. Concordance of waveform features (e.g., timing, shape, amplitude) between
BCG signals and multi-modal sensor outputs 		 At Baseline 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   16/02/2025 
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="0"
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   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.

Currently, TST is focused on investigating unique "M-shaped" respiratory waveforms observed in ballistocardiography (BCG) signals, which are hypothesized to correlate with irregular breathing events. This study aims to collect and analyze controlled, abnormal respiratory patterns in healthy volunteers to better understand these waveforms and their implications. Insights from this analysis will inform the development of advanced detection models for abnormal breathing. By enhancing algorithms for respiratory rate (RR) measurement, this research seeks to improve respiratory monitoring, enabling more effective and non-invasive solutions for both clinical and home-care applications.
 
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