NCT05153122

A Feasibility Study of Wearable Device in Assessing Respiratory Condition Change of Patients With Exacerbation of COPD

A Feasibility Study of Evaluation of SenseGuard, Non-Invasive Wearable Device, in Assessing Respiratory Condition Change of Patients With Exacerbation of Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: NanoVation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will include daily SenseGuard measurement of patients hospitalized with exacerbations of COPD. from admission to discharge. In parallel clinical evaluation of patient's respiratory condition was done daily by routine tests and questionnaires.

Detailed description

A study for evaluating the feasibility of SenseGuard in assessing the respiratory condition change of hospitalized patients with exacerbation of COPD, by monitoring respiratory parameters. The study duration for each patient will start at the time of enrollment until the patient is released, or until the optional post-discharge follow-up visit. The study will include at least one visit per day: The visit and measurement with SenseGuard will start prior to the first medical exacerbation treatment effect-onset given on each study day (by inhalation or IV). The measurement with SenseGuard will be done before and after treatment. At the investigator discretion, additional two similar visits could be performed on the same study day, with or without the admission of the medical exacerbation treatment. During the study, both the investigator and the patients will be asked to fill questionnaires to assess the patient's condition Additionally, measurements that are performed and collected as a standard practice or at the request of the medical personnel as part of patient's treatment course shall be documented and used as a reference for the study device assessment.

Conditions

• COPD Exacerbation

Interventions

Type	Name	Description
DEVICE	SenseGuard	SG is a wireless, wearable medical device, which includes nano-based sensors. It can seamlessly measure patient's tidal breathing during daily activities. SG extracts series of critical respiratory parameters, including; Respiration Rate (RR), Inhalation and Exhalation duration and ratio (I/E), as well as novel biomarkers. SG parameters are applicable to evaluate COPD patients' condition, or for monitoring patients with other respiratory conditions. SG components are: RSM (Respiratory Sensing Module): non-invasive module with sensors that can detect the exhaled humidity and condensation. The RSM is a non-sterile, disposable, single patient use. ECU (Electronic Control Unit): a re-usable, wireless data acquisition and transmission unit. The ECU is connected to the RSM during the measurement and transmits the data via Bluetooth to the SG software. SenseGuard™ Software: for data management, acquisition, processing, logging and presentation of the digital respiratory signals.

Timeline

• Start date: 2020-08-11
• Primary completion: 2022-05-25
• Completion: 2023-05-25
• First posted: 2021-12-10
• Last updated: 2024-03-26

Locations

2 sites across 2 countries: Germany, Israel