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CTRI Number  CTRI/2024/04/066300 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical trial to study the accuracy of a novel technology-enabled tool to identify the risk of dyslexia in children aged 6 to 10 years. 
Scientific Title of Study   Gaze Pattern Based Screening For Early Identification Of Risk Of Dyslexia In School Children. 
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Teena Ajit Paul 
Designation  Founder and CEO 
Affiliation  Giftolexia Solutions Private Limited 
Address  #677, 1st Floor, 27th Main, 13th Cross, HSR Layout, Sector 1, Bengaluru.

Bangalore
KARNATAKA
560102
India 
Phone  7406722955  
Fax    
Email  teena@giftolexia.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nayanabai Shabadi 
Designation  Assistant Professor 
Affiliation  JSS Medical College, Mysuru 
Address  Department of Community Medicine, JSS Medical College, SS Nagar, Bannimantap, Mysuru-

Mysore
KARNATAKA
570015
India 
Phone  8105828888  
Fax    
Email  nayanabaishabadi@jssuni.edu.in  
 
Details of Contact Person
Public Query
 
Name  Teena Ajit Paul 
Designation  CEO 
Affiliation  Giftolexia Solutions Private Limited 
Address  #677, 1st Floor, 27th Main, 13th Cross, HSR Layout, Sector 1, Bengaluru

Bangalore
KARNATAKA
560102
India 
Phone  7406722955  
Fax    
Email  teena@giftolexia.com  
 
Source of Monetary or Material Support  
Giftolexia Solutions Private Limited, #677, 1st Floor, 27th Main, 13th Cross, HSR Layout, Sector 1, Bengaluru, Karnataka 560102 India  
 
Primary Sponsor  
Name  Teena Ajit Paul 
Address  #677, 1st Floor, 27th Main, 13th Cross, HSR Layout, Sector 1, Bengaluru 560102. 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nayanabai Shabadi  JSS Medical College, Mysuru  Department of Community Medicine, JSS Medical College, SS Nagar, Bannimantap, Mysuru-570015
Mysore
KARNATAKA 
8105828888

nayanabaishabadi@jssuni.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee JSS Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screening for Dyslexia in healthy children aged 6 to 10 years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AI-DST  The screening involves use of a wearable eye tracking device with infrared cameras that track the gaze pattern while children read grade appropriate text on a screen. We use an Eye Tracking device that is safe for use in children. A laptop runs the application that stores the Gaze Data of students. 
Comparator Agent  NIMHANS Battery.  he NIMHANS Neuropsychological Battery for Children (Kar et al., 2004) consists of 13 previously developed tests that assess: Motor speed; Attention; Executive functions; Visuospatial functions; and Comprehension, learning, and memory. All of the tests included in the battery were either originally developed for or standardized on children in the West; there are norms for each test at each age level. In their India-based study with normal school-going children in the age range of 5–15 years, Kar et al. (2011) report that the test–retest reliability of all the tests falls in the range of 0.53–0.83, and that all of the tests have well-established construct validity. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. As participants are underaged, guardian consent and verbal consent from participant will be primary criteria for inclusion.
2.Participants should demonstrate a basic level of reading comprehension in the language the screening is conducted. 
 
ExclusionCriteria 
Details  The following individual will be excluded:
1. non-consenting children.
2. Children with visual impairment.
3. Children with significantly below average intelligence.
4. Children with reading comprehension below the test threshold. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be measured as percent accuracy of the tool determined by comparison with an assessment tool, the NIMHANS Neuropsychological Battery for Children.   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome will be the safety of the device used by recording any negative outcomes.  1 hour from test. 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   06/05/2024 
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="5"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Relevant data will be shared in a publication

  6. For how long will this data be available start date provided 15-02-2024 and end date provided 15-06-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Dyslexia is a neurological disability that affects reading, spelling and language related learning.
About 10 to 15% of the population is believed to be Dyslexic. People with Dyslexia are often perceived to be dull or lazy. On the contrary many famous inventors and scientists are believed to have been Dyslexic. People with Dyslexia are considered to be natural problem solvers and inventors. Early detection and intervention are crucial in tapping their full potential. The present testing processes are not standardized and is time consuming. We have developed a technology enabled screening tool based on gaze pattern analysis. We use a non- intrusive wearable eye tracking device to capture gaze data, a laptop stores the data. A smart IOT enabled screen or TV screen is used to calibrate the eyes and to project age and grade appropriate text
which is read aloud by the child. Markers are extracted from the gaze data, and this is analyzed using machine learning algorithms. Multiple visualizations are also used for human interpretation, verification and correlation to arrive at the risk level of each child. This is an easier and faster screening method and is the best tool for class-wide screening as mandated by the RPWD Act This is age and language specific. The Rights to Persons with Disabilities Act 2016 talks about screening all children before the age of 9.This creates the need for a tech-enabled, standardized early screening tool. We use a globally recognized method of screening and offer the best solution for class-wide screening. Dyslexia is fundamentally a language-based learning disability, our results suggest that eye movements in reading can be highly predictive of individual reading ability and that eye tracking can be an efficient means to identify children at risk of long-term reading difficulties at an early age. This will help in early intervention and saves early crucial learning years and will lead to better learning and success in life.
 
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