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CTRI Number  CTRI/2018/05/013615 [Registered on: 02/05/2018] Trial Registered Retrospectively
Last Modified On: 08/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   cross sectional survey 
Study Design  Other 
Public Title of Study   A study to collect voice samples of patients and healthy individuals having similar age. 
Scientific Title of Study   Survey to collect voice samples of patients and age matched healthy individuals. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharvari Rangnekar 
Designation  Director 
Affiliation  Quest Clinical Services 
Address  14 Samata, Ganesh nagar, chinchwad, Pune 33

Pune
MAHARASHTRA
411033
India 
Phone  9890229919  
Fax    
Email  dr.rangnekar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharvari Rangnekar 
Designation  Director 
Affiliation  Quest Clinical Services 
Address  14 Samata, Ganesh nagar, chinchwad, Pune 33

Pune
MAHARASHTRA
411033
India 
Phone  9890229919  
Fax    
Email  dr.rangnekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharvari Rangnekar 
Designation  Director 
Affiliation  Quest Clinical Services 
Address  14 Samata, Ganesh nagar, chinchwad, Pune 33

Pune
MAHARASHTRA
411033
India 
Phone  9890229919  
Fax    
Email  dr.rangnekar@gmail.com  
 
Source of Monetary or Material Support  
GS Lab 2nd floor to 8th Floor, Amar Arma Genesis, Baner Road, Baner, Pune, Maharashtra 411045 
 
Primary Sponsor  
Name  Gs Lab 
Address  2nd floor to 8th Floor, Amar Arma Genesis, Baner Road, Baner, Pune, Maharashtra 411045 
Type of Sponsor  Other [Computer software developers ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Medha Joshi  Ayurved Rugnalaya &Sterling Multispeciality Hospital  Department of Kayachikitsa, Ground floor, Vitthal Rakhumai Rd, Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA 		 9881465798

medhamaheshjoshi@gmail.com 
Dr Sachin Yadav  Chintamani Hospital   Department of general medicine, First floor, Plot no. 53, Bibwewadi Road, Above Vidya Sahakari Bank, Jedhe Nagar, Bibwewadi, Pune, Maharashtra 411037
Pune
MAHARASHTRA 		 9370250050

drsachinvasantyadav@gmail.com 
Dr Shweta Patil  Dhanvantari Hospital  Sector 27, Tilak Road, Nigdi, Pune, Maharashtra 411044
Pune
MAHARASHTRA 		 02027656950

shwetapatil2886@gmail.com 
Dr Milind Kulkarni  Dr. Kulkarni Clinic  Office no 7, Kasturba Housing society, Gurukrupa complex Vishrantwadi Airport road., Landmark: Above Bhagini Nivedita Sahakari Bank, Pune
Pune
MAHARASHTRA 		 9860312537

drmilindjivi@gmail.com 
Dr Jitendra Agrawal  Surya Prabha Nursing Home  Plot No., 7, Paud Rd, Gujrat Colony, Kothrud, Pune, Maharashtra 411038
Pune
MAHARASHTRA 		 08805598244

shwetapatil2886@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee-DMH RC  Approved 
Maharashtra Medical Research Sociaty  Approved 
Noble Hospital, Institutional Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Depression, Asthma, Parkinson’s disease, Alzheimer’s disease, Congestive Heart Failure, Pregnancy and Maternal Health, and any other disease condition; and age matched healthy people ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.All individuals over 18 years of age
2. Equal numbers of male (3,000) (subject to extension)and female (3,000)(subject to extension) participants
3. Willing and consenting participants
4. Potential participant should be able to read 
 
ExclusionCriteria 
Details  1.People having speech disorder, deafness, blindness or color-blindness
2. People speaking language other than Local, Hindi or English 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To examine linguistic and non-linguistic vocal characteristics in diseased and general population
To assess the feasibility of collecting large-scale, data-rich samples of voice and sound and of extracting linguistic and non-linguistic information from speech and sound samples recorded over a mobile device,
To determine the feasibility of using extracted information to predict demographic (eg. age, gender) and health measures.
 		 As it is a survey, voice samples will be collected from the patients on mobile base app, only once, i.e. at the time of enrollment.
After that collected data will be analysed after completion of the study.  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the feasibility of collecting large-scale, data-rich samples of voice and sound and of extracting linguistic and non-linguistic information from speech and sound samples recorded over a mobile device,
To determine the feasibility of using extracted information to predict demographic (eg. age, gender) and health measures. 		 As it is a survey, voice samples will be collected from the patients on mobile base app, only once, i.e. at the time of enrollment.
After that collected data will be analysed after completion of the study.  
 
Target Sample Size   Total Sample Size="6000"
Sample Size from India="6000" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2018 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Data generated will be analyzed and published in peer reviewed journal.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The content and quality of vocal production may be a valuable marker of health information. Vocal
production, for example speech, contains rich information in both the content (linguistic) and quality (non-linguistic)
characteristics of sound information.
Previous research has used vocal samples to predict important markers of cognitive and affective state. From the
non-linguistic information of speech, including but not limited to the information about the pitch, phonemes, and
power spectrum of the vocal signal, researchers have been able to predict with high accuracy the cognitive load of
an individual at a given moment.We propose to use speech and sound data collected from mobile devices to obtain indices of mental and physical
health. We will collect prompted and free speech from a mobile application, including several different cognitive
tasks (eg. reading a sentence or passage, naming colors) and will collect demographic and questionnaire data. We
will then use a proprietary back-end analysis to extract features and correlate these features to cognitive and
affective measures.
 
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