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

NCT05153122 | Completed

• 1 other identifier: CIV-19-07-029227
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Investigational SenseGuard Device

EXPERIMENTAL

Patients undergo SG monitoring at least twice daily before and after receiving treatment.

Device: SenseGuard

Interventions

SenseGuard DEVICE

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.

Investigational SenseGuard Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Inability to provide informed consent including patients still impacted by the use of narcotics as part of emergency care.
• \. 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.
• \. Presence of implanted electronic device intended to regulate cardiac activity (e.g., pacemaker or cardioverter/defibrillator).
• \. 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.
• \. Participation in another study that is related to treatment of the respiratory condition.

Sponsors & Collaborators

• NanoVation: lead

Study Sites (2)

Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin I

Halle, Germany

Location

Galilee Medical Center

Nahariya, Israel

Location

Study Officials

• Stephan Eisenmann, Dr.

  Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Innere Medizin I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 10, 2021
• Study Start: August 11, 2020
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

DE (1); IL (1)