| CTRI Number |
CTRI/2024/03/064909 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the health status using voice samples of patients having asthma and other. |
|
Scientific Title of Study
|
Modeling of health states using vocal biomarker analysis of passive audio recordings |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SH2024 Version no.1.0 Dated 22Jan2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shashikant Madrewar |
| Designation |
Consultant |
| Affiliation |
Dr Madrevars chest and multispeciality hospital |
| Address |
Ground floor, Room no 2;
Dr Madrevars chest and general hospital,
Shubh Complex, Indrayani Nagar, Above Axis Bank Sector 1, Bhosari, Pune Pune MAHARASHTRA 411039 India |
| Phone |
9850172762 |
| Fax |
|
| Email |
shashi.madrewar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sharvari Rangnekar |
| Designation |
Director |
| Affiliation |
Questt Clinicals and Ayurceuticals Pvt. Ltd. |
| Address |
Second floor, Room no 204, Sun Planet, Sinhagad Road, Pune
Pune MAHARASHTRA 411051 India |
| Phone |
9890229919 |
| Fax |
|
| Email |
questclinicalservices@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sharvari Rangnekar |
| Designation |
Director |
| Affiliation |
Questt Clinicals and Ayurceuticals Pvt. Ltd. |
| Address |
Second floor, Room no 204, Sun Planet, Sinhagad Road, Pune
Pune MAHARASHTRA 411051 India |
| Phone |
9890229919 |
| Fax |
|
| Email |
questclinicalservices@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sonde Health |
| Address |
502 B2 Wing Kanta Residency Opp to Gharonda Hotel Morwadi Pimpri Pune 411018
|
| Type of Sponsor |
Other [Private Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lakshimikant Yende |
Deenanath Mangeshkar Hospital |
Respiratory Medicine Annex Building, Erandawane, Pune Pune MAHARASHTRA |
7769056997
laxmikantbyenge@outlook.com |
| Dr Shashikant Madrewar |
Dr Madrewars chest and general hospital |
Block no 2, Ground floor, Shubh Complex, Indrayani Nagar, Above Axis Bank Sector 1, Bhosari, Pune Pune MAHARASHTRA |
9850172762
shashi.madrewar@gmail.com |
| Dr Milind Kulkarni |
Kulkarni Clinic |
Office no 7, First floor, Gurukrupa Complex ,
Kasturba housing society ,
Above Bhagini Nivedita Bank,
Vishrantwadi- airport road
Vishrantwadi , Pune.411015
Maharashtra 411015 Pune MAHARASHTRA |
9860312537
drmilindjivi@gmail.com |
| Dr Sahebrao Toke |
Ojas Multispeciality Hospital |
Room no 1, Ground floor, Medicine department, Ojas hospital, Bhondave Chowk, Ravet, Pune Pune MAHARASHTRA |
9962264354
dr.sahebrao@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Biomedical and Health Research |
Approved |
| Royal Pune Independant Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Agreement with the subject consent information presented on the Sonde app.
2. Stated willingness and ability to comply with all study procedures
3. Male or female, aged 18 or above
4. Fluent in any of the designated languages selected for the study
5. Pregnant women are allowed to participate
6. Have a medical diagnosis of asthma or COPD if participating as a patient (asthma and COPD as comorbidities are allowed)
7. No respiratory diagnosis if participating as non-patient volunteer. Non-respiratory diagnoses are allowed unless mentioned in the exclusion criteria
|
|
| ExclusionCriteria |
| Details |
1. Speech or voice disorder (known diagnosis or clinician judgment)
2. Patient in critical conditions requiring immediate medical attention
3. Chronic respiratory conditions other than asthma or COPD
4. Acute respiratory conditions (upper or lower respiratory tract viral or bacteriological infections)
5. Participation in medication studies or trials
6. Severe psychiatric diagnosis (e.g. schizophrenia, psychotic disorder)
7. Dementia, Alzheimer’s Disease, or similar cognitive impairment diagnosis
8. Movement disorder (e.g. Parkinson’s Disease, Huntington’s Disease)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Dataset Compilation: To compile a comprehensive reference dataset of vocal samples, gathered passively from individuals with respiratory conditions as well as healthy volunteers, to serve as a benchmark for analysis. |
Day zero (baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Authentication Algorithm Assessment: To assess the feasibility & accuracy of user authentication algorithms by analyzing voice samples collected passively, ensuring reliable participant identification.
3. Vocal Feature Analysis: To conduct a comparative analysis of vocal & prosodic features between passively collected voice samples & those obtained through cued vocal elicitations, to validate the efficacy of passive collection methods.
4. Respiratory Condition Modeling: To develop robust predictive models that utilize passively collected voice samples to diagnose & monitor respiratory conditions & symptoms.
5. Mental Health Assessment Models: To create predictive models that can evaluate the severity of self-reported mental health symptoms using the vocal features derived from passively collected voice samples.
|
Day zero (baseline) |
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
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)
|
08/04/2024 |
| 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="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 designed to refine vocal analysis techniques by integrating distinct vocal characteristics, known as vocal biomarkers (VB), which are indicative of a variety of health states. Conventionally, VB development has utilized "cued" voice samples—these are recordings captured when participants are prompted to produce sounds or speech based on specific guidelines. Established VB models have shown success in discerning between certain respiratory conditions (such as asthma, chronic obstructive pulmonary disease (COPD), and COVID-19) and healthy states, through the elicitation of sustained vowel sounds, particularly the "ahh" sound. Moreover, analyses of vocal features from 30-second segments of natural speech have been effective in differentiating levels of mental health symptomatology. This research intends to advance the application of VB methods to "passive" voice recordings. These recordings are captured via devices that continuously process audio data and identify individual users without active user engagement. By utilizing these passively obtained signals for VB analysis, the study aims to remove the requirement for overt participant interaction, thereby allowing the technology to function unobtrusively, much like current fitness tracking devices. To achieve this transition, it is necessary to adapt the established cued VB techniques to a passive collection environment. This adaptation will require the compilation of a new passive VB dataset, which will then be compared and validated against cued recordings from the same participants. The successful completion of this process is crucial to enhance the practicality and efficacy of VB technology for health state assessment. · Respiratory Patients: 400 adults with Asthma (200) or COPD (200). · Healthy Volunteers: 100 adults without any chronic or acute health, especially respiratory conditions. Criteria: · Age: 18+ Gender: Balanced male and female representation
The Sonde One app will be used to collect voice samples and health information from participants. This is an observational study without intervention. Participant Duration: Single visit, approximately 30 minutes. |