| CTRI Number |
CTRI/2026/01/101149 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Measure Blood Pressure Using a Light Sensor Placed on the Finger |
|
Scientific Title of Study
|
Blood Pressure monitoring using photo plethysmography |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MUTHINENI HANEESH |
| Designation |
Post graduate, General Medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai TAMIL NADU 602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7013530219 |
| Fax |
|
| Email |
haneesh9999hani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Kumar |
| Designation |
Professor, Dept of General Medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
99764 16171 |
| Fax |
|
| Email |
docrk83@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr MUTHINENI HANEESH |
| Designation |
Post graduate, General Medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai
Chennai TAMIL NADU 602105
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7013530219 |
| Fax |
|
| Email |
haneesh9999hani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105, Chennai, Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai, Tamil Nadu 602105 |
| 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 |
| Dr Muthineni Haneesh |
Saveetha Medical College and Hospital |
Room No. 1, Department of General Medicine, Saveetha Medical College and Hospital
Kancheepuram
TAMIL NADU |
7013530219
haneesh9999hani@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: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 years and older, both with normal and elevated blood pressure.
2. Clinically stable individuals without acute cardiovascular conditions or severe
hypertension.
3. Participants able to provide informed consent.
4. No severe peripheral arterial disease or significant dermatological conditions
that could interfere with PPG measurements.
5.Willingness to undergo repeated BP measurements using both PPG and traditional
cuff methods. |
|
| ExclusionCriteria |
| Details |
1.Age above 80 years or age less than 18 years
2. Inability to consent
3. Severe Cardiovascular Conditions
4. Patients with peripheral vascular disease, Raynaud’s disease, vasculitis.
5. Severe Dermatological Conditions :open wounds, severe eczema, or psoriasis
6. Pregnancy
7. Motion Disorders:Parkinson’s disease that could interfere with the PPG
signal. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy and agreement of blood pressure readings obtained using a photoplethysmography (PPG) device compared with standard cuff-based measurements |
Single time point at baseline during the same study visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feasibility and ease of use of the PPG-based blood pressure device. |
Assessed once during the study visit |
|
|
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)
|
30/01/2026 |
| 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 Applicable |
| 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 study aims to evaluate a non-invasive method of measuring blood pressure using a light-based sensor called photoplethysmography (PPG). Participants will undergo a single-visit assessment where blood pressure will be measured using both the PPG device and the standard cuff method. The readings will be compared to understand how closely the PPG device matches the standard method. The study also assesses the ease of use of the PPG device and the quality of the recorded signals. No drugs or interventions are given, and the procedure is safe, quick, and completely non-invasive.
|