| CTRI Number |
CTRI/2024/12/077729 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical validation study to assess the performance of the BP Band device to measure blood pressure in people with both normal and high blood pressure compared to the standard mercury BP apparatus. |
|
Scientific Title of Study
|
Clinical Validation Study of BP BAND:
A continuous, cuffless blood pressure monitoring device |
| 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 Arun P Jose |
| Designation |
Head, BRIDGE Centre for Digital Health & Deputy Director, Centre for Chronic Disease Control (CCDC) |
| Affiliation |
Centre for Chronic Disease Control (CCDC) |
| Address |
C-1/52, 2ND Floor, Bridge Centre for Digital Health, Safdarjung Development Area, New Delhi, Delhi 110016
New Delhi
DELHI
110016
India |
| Phone |
|
| Fax |
|
| Email |
arunp.jose@ccdcindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akansha Kumari |
| Designation |
Project Coordinator |
| Affiliation |
Centre for Chronic Disease Control (CCDC) |
| Address |
C-1/52, 2ND Floor, Bridge Centre for Digital Health, Safdarjung Development Area, New Delhi, Delhi 110016
New Delhi
DELHI
110016
India |
| Phone |
8766280298 |
| Fax |
|
| Email |
akansha@ccdcindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akansha Kumari |
| Designation |
Project Coordinator |
| Affiliation |
Centre for Chronic Disease Control (CCDC) |
| Address |
C-1/52, 2ND Floor, Bridge Centre for Digital Health, Safdarjung Development Area, New Delhi, Delhi 110016
New Delhi
DELHI
110016
India |
| Phone |
8766280298 |
| Fax |
|
| Email |
akansha@ccdcindia.org |
|
|
Source of Monetary or Material Support
|
| Imedrix Systems Pvt Ltd, UKS Heights, M20, Jeevan Bima Nagar Main Rd, LIC Colony, HAL 3rd Stage, Sector 11, New Tippasandra, Bengaluru, Karnataka, India 560075. |
|
|
Primary Sponsor
|
| Name |
Imedrix Systems Pvt Ltd |
| Address |
M20, UKS Heights, Jeevan Bima Nagar Main Rd, LIC Colony, HAL 3rd Stage, Sector 11, New Tippasandra, Bengaluru, Karnataka 560075, India |
| Type of Sponsor |
Other [Biomedical technology company] |
|
|
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 Deepak Padmanabhan |
Narayana Institute of Cardiac Sciences |
#258/A, Bommasandra Industrial Area, Anekal Taluk, Bengaluru 560099, India
Bangalore
KARNATAKA |
7030133220
deepak.padmanabhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics Committee, Narayana Health |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hypertension |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants with normal BP, prehypertension, stage 1 hypertension, and stage 2 hypertension.
Participants who provide voluntary informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Pregnant women, paediatric, or elderly individuals above the age of 65.
Participants with present arrhythmias. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bland-Altman plot analysis will determine the Limits of Agreement (LoA) and their confidence intervals (CI). Agreement is concluded if the confidence intervals lie within the predefined boundary of ±7 mmHg. |
Measured at baseline and again within 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean differences in systolic & diastolic BP over repeated measurements using Bland-Altman analysis. |
Measured at baseline & again within 4 weeks |
| Accuracy of BP Band in distinguishing BP ranges (normal, prehypertension, stage 1 & 2 hypertension). |
Measured at baseline & again within 4 weeks |
| Participant adherence rates & feedback on usability through structured surveys. |
Measured at baseline & again within 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/12/2024 |
| 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="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 check the accuracy and reliability of the photoplethysmography (PPG) based cuffless blood pressure (BP) monitoring band in comparison to the gold standard mercury sphygmomanometer across a spectrum of BP readings, ranging from normotensive to hypertensive levels. The proposed study design is an observational descriptive study to validate the cuffless BP monitoring device against the gold standard Mercury Sphygmomanometer. The study will be coordinated from the Centre for Chronic Disease Control in New Delhi and conducted at the Narayana Institute of Cardiovascular Sciences in Bangalore. The study population will comprise 360 participants aged between 21 and 65 years, with blood pressure levels ranging from normal to pre-hypertension, and stage I and stage II hypertension, ensuring equal representation across these categories.
The procedure involves training 2 observers who will measure BP in a static position in a controlled environment. Follow-up tests will be conducted after 2 days not exceeding 28 days. During these tests, measurements will be obtained using both the BP Band and Mercury Sphygmomanometer, which will be used as a reference. |