临床试验/CTRI/2025/05/087463

CTRI/2025/05/087463尚未招募不适用

Clinical Validation of a Novel Compound Diagnostic Unit, NIBRA-CS for Assessment of Autonomic Neuro-Function Integrity

Department of Science and Technology1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2025年6月9日最近更新: 2025年5月22日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Department of Science and Technology
入组人数: 100
试验地点: 1
主要终点: Comparing two data sets using Bland-Altman Plot

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A simple, portable, independent and stand-alone system with minimal infrastructural requirement device, called Non-Invasive Baro-Reflex Assessment – Combined System (NIBRA-CS™) has been developed. Preliminary validation of the prototype has been done against a similar, commonly used device, “KODYSCAN” of Kody Medical Electronics Private Limited. The present study aims to validate this NIBRA-CS™, against an existing device (KODYSCAN) for analysis of autonomic neurofunction based on a combination of Ewing’s battery of tests and short-term heart rate variability.

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 16.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Healthy (asymptomatic) individuals of age between 16 and 65 years and of both gender residing in an urban community of Kolkata.

排除标准

•Those who deemed physically unfit by the investigators to undergo autonomic function tests.

结局指标

主要结局

Comparing two data sets using Bland-Altman Plot

时间窗: Single

次要结局

Time taken for completing the screening(Baseline)
Ease of Operability(Baseline)

研究者

发起方

Department of Science and Technology

申办方类型

Government funding agency

责任方

Principal Investigator

主要研究者

Rohan Tripathi

Inovocare Healthsoft Solutions Pvt Ltd, Kolkata

研究点 (1)

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