跳至主要内容
临床试验/CTRI/2025/02/080139
CTRI/2025/02/080139招募中不适用

Assessment of Abnormal Respiratory Patterns Using a Non-Invasive Ballistocardiography Device

Turtle Shell Technologies Pvt Ltd2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Identification and characterization of "M-shaped" respiratory waveforms in

研究概览

简要总结

Turtle Shell Technologies Pvt. Ltd.’s (TST) Dozee system is a non-invasive continuous vitals monitoring system. The device employs piezoelectric sensors to capture micro-vibrations caused by cardiac contractions, upper respiratory tract activity, and body movements. It is based on the concept of ballistocardiography (BCG). The Dozee system is made up of non-contact sensor sheet(s) whose signals are used to calculate HR, RR, and non-contact blood pressure (NcBP). To measure temperature,  SpO2, and NiBP, contact accessories such as pulse oximeter, temperature probe, and cuff BP  respectively have been integrated.

Currently, TST is focused on investigating unique "M-shaped" respiratory waveforms observed in ballistocardiography (BCG) signals, which are hypothesized to correlate with irregular breathing events. This study aims to collect and analyze controlled, abnormal respiratory patterns in healthy volunteers to better understand these waveforms and their implications. Insights from this analysis will inform the development of advanced detection models for abnormal breathing. By enhancing algorithms for respiratory rate (RR) measurement, this research seeks to improve respiratory monitoring, enabling more effective and non-invasive solutions for both clinical and home-care applications.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Consenting adults of age 18 to 65 years Weight between 40kg to 120kg Able to provide a written consent.

排除标准

  • Weight below 40 kgs and above 120 kgs Currently pregnant Exhibit injuries deformities or other abnormalities that in the opinion of the investigator may prevent proper placement of accessories A significant medical condition in the judgment of the investigator, which may compromise the study testing procedures.

结局指标

主要结局

Identification and characterization of "M-shaped" respiratory waveforms in

时间窗: Baseline

BCG signals across various controlled breathing scenarios.

时间窗: Baseline

Quantification of the frequency and consistency of "M-shaped" waveforms in

时间窗: Baseline

relation to specific respiratory patterns.

时间窗: Baseline

Statistical metrics describing waveform variability, including amplitude,

时间窗: Baseline

duration, and shape consistency.

时间窗: Baseline

次要结局

  • 1. Changes in waveform morphology, amplitude, and frequency during different(breathing patterns.)

研究者

发起方
Turtle Shell Technologies Pvt Ltd
申办方类型
Other [Medical Device Company]
责任方
Principal Investigator
主要研究者

Dr Anindya Dasgupta

Turtle Shell Technologies Pvt Ltd

研究点 (2)

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