| CTRI Number |
CTRI/2026/02/103462 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
“Use of a Smart Wearable Device to Detect Seizures Early and Improve Safety in People with Epilepsy” |
|
Scientific Title of Study
|
Integrating AI Driven Wearable Technology for Real Time Seizure Detection and Monitoring |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karumudi Sindhu |
| Designation |
Postgraduate |
| Affiliation |
Saveetha medical college |
| Address |
Department of General Medicine,
Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam,
Chennai – 602105, Tamil Nadu, India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9885577066 |
| Fax |
|
| Email |
sindhukarumudi7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gunasekaran N |
| Designation |
Professor |
| Affiliation |
Saveetha medical college |
| Address |
Department of General Medicine,
General Medicine Division,
Professor Room,
Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam,
Chennai – 602105, Tamil Nadu, India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9884398420 |
| Fax |
|
| Email |
drguna59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karumudi Sindhu |
| Designation |
Postgraduate |
| Affiliation |
Saveetha medical college |
| Address |
Department of General Medicine,
General Medicine Division,
Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam,
Chennai – 602105, Tamil Nadu, India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9885577066 |
| Fax |
|
| Email |
sindhukarumudi7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Department of General Medicine,
Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam,
Chennai – 602105, Tamil Nadu, India |
| Type of Sponsor |
Private 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 |
| Karumudi Sindhu |
Saveetha medical college |
Department of General Medicine,
General Medicine Division,
Room No: 311
Kancheepuram
TAMIL NADU |
9885577066
sindhukarumudi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G409||Epilepsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 65 years with a confirmed diagnosis of epilepsy.
Patients with a history of recurrent seizures.
Individuals on stable antiepileptic treatment for at least three months.
Participants willing to wear the wearable monitoring device.
Written informed consent obtained |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of the AI enabled wearable device for detection of seizure events |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time delay between seizure onset and alert generation by the wearable device |
During seizure events throughout the 6 month monitoring period
|
|
|
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)
|
15/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective observational study aims to evaluate an AI-driven wearable device for real-time seizure detection in adults with epilepsy. A total of 200 participants will be monitored continuously over a 6-month period using the wearable technology. The primary outcome is the accuracy of seizure detection, assessed by sensitivity and specificity compared with clinical seizure documentation. The study seeks to determine the feasibility and reliability of wearable AI systems in improving real-time seizure monitoring and patient safety.
|