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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  
Nil 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 Â·       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.

 
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