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

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.

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation
• Intervention / Treatment: Device: SenseGuard

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronit Shtrichman, Dr.; Phone Number: 972526500938; Email: ronit@nanovation-gs.com

Study Locations

• Germany
  • Halle, Germany
    • Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin I
• Israel
  • Nahariya, Israel
    • Galilee Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Primary or secondary diagnosis of AECOPD (Acute Exacerbation of Chronic Obstructive Pulmonary Disease) in patients with GOLD 1-4/A-D
2. WHO performance status ≤ 3
3. Provision of signed and dated informed consent form.
4. Male or female, aged ≥18.
5. Ability and stated willingness to adhere to the study regimen and availability for the duration of the study.

Exclusion Criteria:

3. Inability to provide informed consent including patients still impacted by the use of narcotics as part of emergency care.

4. Intubated patients or patients undergoing a BIPAP/CPAP/NHF treatment and are medically not able to suspend the treatment for the required duration of the visits or expected intolerance of the sensor in their face due to severe respiratory distress.

5. Presence of implanted electronic device intended to regulate cardiac activity (e.g., pacemaker or cardioverter/defibrillator).

6. Pregnancy or lactation. 7. Known allergic reactions to materials used in the components of the SenseGuard™ system, i.e. polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.

8. Participation in another study that is related to treatment of the respiratory condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Investigational SenseGuard Device; Patients undergo SG monitoring at least twice daily before and after receiving treatment.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of SenseGuard respiratory parameter - Respiratory Rate, in the measurement of clinical change in COPD patients hospitalized with AECOPD	SenseGuard respiratory parameters (Respiratory Rate in BPM ) can be used to assess the changes in respiratory condition of 80% of exacerbated COPD patient, as defined by physician's assessment, patient's self-assessment and/or as measured by current conventional methods.	24 months
Evaluation of SenseGuard respiratory parameter - Inhalation to Exhalation ratio, in the measurement of clinical change in COPD patients hospitalized with AECOPD	SenseGuard respiratory parameters (Inhalation and Exhalation time and ratio) can be used to assess the changes in respiratory condition of 80% of exacerbated COPD patient, as defined by physician's assessment, patient's self-assessment and/or as measured by current conventional methods.	24 months

Collaborators and Investigators

• Sponsor: NanoVation
• Investigators: Principal Investigator: Stephan Eisenmann, Dr., Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin I

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CIV-19-07-029227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No