| CTRI Number |
CTRI/2024/01/062026 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Identifying breathing problems through artificial intelligence |
|
Scientific Title of Study
|
Validation & Deployment of Swaasa AI Platform for screening & triaging of respiratory problems |
| 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 Chythra R Rao |
| Designation |
Additional Professor |
| Affiliation |
|
| Address |
Room no. 1, Dept. of Community Medicine, Kasturba Medical College,Manipal Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chythra R Rao |
| Designation |
Additional Professor |
| Affiliation |
|
| Address |
Room no. 1, Dept. of Community Medicine, Kasturba Medical College,Manipal Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chythra R Rao |
| Designation |
Additional Professor |
| Affiliation |
|
| Address |
Room no. 1, Dept. of Community Medicine, Kasturba Medical College,Manipal Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Salcit Technologies |
| Address |
Jayabheri Silicon County, Upper Stilt Level, Beta Block, Hitech City Rd, Kothaguda, Telangana |
| Type of Sponsor |
Other [Private institution] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chythra R Rao |
Kasturba Medical College |
Room no. 1, Dept. of Community Medicine, Kasturba Medical College, Manipal, MAHE, Manipal
Udupi
KARNATAKA |
9448857793
chythra.raj@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spirometry and Chest Xray |
Spirometry and Chest Xray will be done to confirm respiratory illness |
| Intervention |
Swaasa AI application |
cough sounds will be tested on Swaasa AI application to detect repiratory illness |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Cases
Inclusion criteria:
1.Participants 18 years of age and over.
2.Equal distribution of male and females.
3.Proportionate distribution in different age groups.
4.Patients able to read, understand and sign the Informed Consent Form.
5.Patients covering both symptomatic (with respiratory complaints such as a new or worsened respiratory condition, acute cough, or onset of shortness of breath and respiratory diseases like Asthma, Bronchitis, COPD, ILD, Pneumonia and others)).
6.Smokers and nonsmokers
|
|
| ExclusionCriteria |
| Details |
Participants with severe illness or recent surgeries
Pregnant females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validation of Swaasa AI platform |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time & cost reduction |
one year |
|
|
Target Sample Size
|
Total Sample Size="15200"
Sample Size from India="15200"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 Swaasa platform brings a
revolutionary approach to respiratory healthcare. It identifies (a) if there is an underlying respiratory condition
(b) whether the condition is normal/obstructive/restrictive/mixed/inconclusive
and (c) the level of severity. It also provides additional information on dry and
wet cough count. All of this is
accomplished in seconds based on a patient coughing into a smartphone.
|