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

NCT05153122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-03-26

No results posted yet for this study

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.

Conditions

  • COPD Exacerbation

Interventions

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.

Sponsors & Collaborators

  • NanoVation

    lead INDUSTRY

Principal Investigators

  • Stephan Eisenmann, Dr. · Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin I

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2022-05-25
Completion
2023-05-25

Countries

  • Germany
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153122 on ClinicalTrials.gov