| CTRI Number |
CTRI/2024/10/075990 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of the AudibleHealth DxPro AI/ML-Based CDSS Using FCV-SDS in Screening for Tuberculosis |
|
Scientific Title of Study
|
Evaluation of the Artificial Intelligence/Machine Learning-based Clinical Decision Support Software Using Forced Cough Vocalization Signal Data Signatures in Screening for Tuberculosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nll |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Raina |
| Designation |
Professor & Head |
| Affiliation |
Dr RPGMC Tanda Kangra |
| Address |
Department of Community Medicine Paraclinical Block Third Floor Dr Rajendra Prasad Government Medical College Tanda HP
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418061066 |
| Fax |
|
| Email |
ojasrainasunil@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Raina |
| Designation |
Professor & Head |
| Affiliation |
Dr RPGMC Tanda Kangra |
| Address |
Department of Community Medicine Paraclinical Block Third Floor Dr Rajendra Prasad Government Medical College Tanda HP
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418061066 |
| Fax |
|
| Email |
ojasrainasunil@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Raina |
| Designation |
Professor & Head |
| Affiliation |
Dr RPGMC Tanda Kangra |
| Address |
Department of Community Medicine Paraclinical Block Third Floor Dr Rajendra Prasad Government Medical College Tanda HP
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418061066 |
| Fax |
|
| Email |
ojasrainasunil@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Community Medicine Dr Rajendra Prasad Government Medical College Tanda Kangra 176001 HP |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Tanda Kangra |
| Address |
Dr Rajendra Prasad Government Medical College Tanda 176001 Kangra HP |
| Type of Sponsor |
Government medical college |
|
|
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 Sunil Raina |
Dr Rajendra Prasad Government Medical College, Tanda |
Department of Community Medicine Paraclinical Block Third Floor Room no 833 Dr Rajendra Prasad Government Medical College Tanda 176001 HP
Kangra
HIMACHAL PRADESH |
9418061066
ojasrainasunil@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RP Govt. Medical College Tanda Kangra Himachal Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A15||Respiratory tuberculosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AudibleHealth DxPro Clinical Decision Support Software (CDSS) |
The AudibleHealth DxPro is a clinical decision support software (CDSS) consisting of an ensemble of software subroutines that interacts with a proprietary database of Signal Data Signatures (SDS), using Artificial Intelligence/Machine Learning (AI/ML) to analyze forced cough vocalization signal data signatures (FCV-SDS) for screening purposes. The intervention will be used for 6 months and will be applied/used daily on the patients. |
| Comparator Agent |
Standard Diagnostic Test Cartridge Based Nucleic Acid Amplification Test |
CB-NAAT test analyzes the DNA of TB bacteria in a sputum sample to identify the presence of Mycobacterium tuberculosis and rifampicin resistance. It is a gold standard for detecting active TB infections and is ideal for early diagnosis and treatment.
CBNAAT of the patients will be performed as per the standard protocol of the hospital. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
·5 years of age and older
·Patients suggestive of pulmonary tuberculosis
·Stated willingness to comply with all trial procedures and availability for the duration of the trial
·Informed consent must be obtained before testing; completed by the subject, parent or guardian, or an emancipated minor
·Successful cough submission after applying any necessary filters on the SaMD |
|
| ExclusionCriteria |
| Details |
·Under 5 years of age
·Unable to produce a voluntary forced cough vocalization (FCV)
·Recent (within the last year) acute traumatic injury to the head, neck, throat, chest, abdomen, or trunk
·Patent tracheostomy stoma
·Recent (within the last year) chest/abdomen/trunk trauma or surgery, recent/persistent neurovascular injury or recent intracranial surgery
·Medical history of cribriform plate injury or cribriform plate surgery, diaphragmatic hernia, external beam neck/throat / maxillofacial radiation, phrenic nerve injury/palsy, radical neck/throat/maxillofacial surgery, vocal cord trauma or nodules
·Since persons with aphasia may have difficulty in producing an FCV-SDS in the time allotted by the app, this population also will be excluded from the current trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of the intervention being used. |
The outcomes will be assessed at the baseline and thereafter every month till six months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To ensure that the device is user friendly in accordance with REASSURED criteria from WHO |
At end of data collection |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/11/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Participants
with symptoms suggestive of pulmonary tuberculosis will be enrolled. The
evaluation tests as per the standard protocols will be performed to confirm the
diagnosis of pulmonary TB in this identified cohort. In
addition, an AudibleHealth DxPro test will be performed on all these patients. Subjects
and staff will be blinded to AudibleHealth DxPro results. No one will know both
results in real-time except for the Site Coordinators specifically authorized
to have these results for enrollment, audit, data tracking, and data compiling
purposes. Unblinding
of the results will occur after the AudibleHealth DxPro and the routine
diagnostic test results have been obtained. |