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CTRI Number  CTRI/2024/01/061796 [Registered on: 24/01/2024] Trial Registered Prospectively
Last Modified On: 23/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Lung function test devices used are bulky and difficult to interpret in Chronic Obstructive Lung Disease. Smart Spirometer and Smart Mask are wireless devices which aim to overcome this. This study compares these results with existing Lung Function device.  
Scientific Title of Study   Clinical Validation of Internet of Things (IoT) based Smart Spirometer and Smart Mask for COPD patients 
Trial Acronym  COPD and Smart Spirometer  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishnarajasekhar Ottilingam Radhakrishnan 
Designation  Professor of Respiratory Medicine  
Affiliation  Saveetha Institute of Medical and Technical Sciences, Saveetha University 
Address  Room No.404, 4th Floor, Saveetha Medical College and Hospital, Thandalam, Kancheepuram

Kancheepuram
TAMIL NADU
602105
India 
Phone  919444018076  
Fax    
Email  krishnarajasekhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Krishnarajasekhar Ottilingam Radhakrishnan 
Designation  Professor of Respiratory Medicine  
Affiliation  Saveetha Institute of Medical and Technical Sciences, Saveetha University 
Address  Saveetha Medical College and Hospital, Thandalam, Kancheepuram

Kancheepuram
TAMIL NADU
602105
India 
Phone  919444018076  
Fax    
Email  krishnarajasekhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Krishnarajasekhar Ottilingam Radhakrishnan 
Designation  Professor of Respiratory Medicine  
Affiliation  Saveetha Institute of Medical and Technical Sciences, Saveetha University 
Address  Saveetha Medical College and Hospital, Thandalam, Kancheepuram

Kancheepuram
TAMIL NADU
602105
India 
Phone  919444018076  
Fax    
Email  krishnarajasekhar@gmail.com  
 
Source of Monetary or Material Support  
Sponsored Research and Industrial Consultancy SRIC, Indian Institute of Technology, Kharagpur 721302 West Bengal 
 
Primary Sponsor  
Name  Ministry of Electronics and Information Technology (MeitY), Government of India  
Address  Ministry of Electronics and Information Technology (MeitY), Government of India, Electronics Niketan, 6, CGO Complex, Lodhi Road, New Delhi 110003 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Sponsored Research and Industrial Consultancy SRIC Indian Institute of Technology Kharagpur  Dr. Dipak Kumar Goswami, Professor,Department of Physics, Organic Electronics Laboratory (ORELA), Indian Institute of Technology Kharagpur, Kharagpur 721302 West Bengal 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr O R Krishnarajasekhar   SIMATS, Saveetha University, Saveetha Medical College and Hospital   Department of Respiratory Medicine, 4th Floor, Room No. 404
Kancheepuram
TAMIL NADU 		 4466726611-2404

respiratory.smc@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
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  Age more than 18 years.
Modified Medical Research Council grade 0 to 3.
Post bronchodilator Spirometry values less than or equal to 0.7.
Spirometry COPD GOLD Grade 1-3. 
 
ExclusionCriteria 
Details  Age less than 18 years
Modified Medical Research Council grade 4
Spirometry GOLD Grade 4
Pregnant Women
Extensive Bronchiectasis, Cystic Fibrosis)
History of other Lung diseases (e.g. Pulmonary Tuberculosis, Pulmonary Fibrosis
Previous Lung Surgery
Active Cancer under Treatment, Suspected Lung Cancer
Metal in the Chest
Recent Eye Surgery
Myocardial Infarction, Unstable Angina
Recent Chest or Abdominal Surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Age, sex and comorbidities are measured. The sensitivity, specificity, positive and negative predictive value and likelihood ratio between the three devices for detection of obstruction.  Time points will be assessed at baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
To collect data on usability evaluation of these devices by the patients, operator & investigators.  Time points will be assessed at baseline. 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
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)   21/02/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [krishnarajasekhar@gmail.com].

  6. For how long will this data be available start date provided 23-12-2024 and end date provided 23-11-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The project involves testing of Internet of Things based Smart Mask and Smart Spirometer developed and prototyped by IIT Kharagpur. Since the currently used Commercial Spirometer is cumbersome and standalone machine, the need for more flexible, robust, point of care devices are the need of the hour. In addition, the existing devices are not sensitive in detecting early forms of COPD. If more handy, remotely connected devices are validated it could be a game changer in the context of COVID-19 or in assessing patients remotely and suggesting modification of treatment by physician or advising admission, which could be life saving. Therefore in the era of precision medicine there is immense utility especially when India is facing an ongoing COPD epidemic. 
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