Clinical Evaluation of SenseGuard™ to Detect Respiratory Changes, During Home Monitoring of Subjects With High Risk of AECOPD.

NCT05119374 | Completed

• 1 other identifier: PD-CLN-003
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 6

Brief Summary

This is an observational, open labeled study. The study aims to evaluate the capability of SenseGuard™ (SG) non-invasive wearable device, to detect, post-hoc, early respiratory changes due to exacerbation by daily monitoring of subjects with COPD, at home. Subjects with COPD, that were discharged following hospitalization due to AECOPD are most susceptible to experience another exacerbation during the first 6 months post admission. Hence, subjects that were discharged from the hospital due to AECOPD during the last 3 months are eligible to the study.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Significant changes in SenseGuard device respiratory parameters (Ratio of Inhalation to exhalation time) can indicate for early exacerbation of COPD patient.

  60% of confirmed COPD exacerbations can be detected in post-hoc analysis of changes in tidal breathing parameters measured by SenseGuard™ (significant change from baseline of Ratio of Inhalation to Exhalation time).

  6 months

Secondary Outcomes (1)

• Rate of retention and Compliance of COPD patients who use SG for home monitoring

  6 months

Study Arms (1)

Investigational SenseGuard Device

EXPERIMENTAL

All subjects use SenseGuard Device for twice daily monitoring of respiratory parameters.

Device: SenseGuard Investigational Device

Interventions

SenseGuard Investigational Device 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:

• Male or female, aged ≥18.
• Diagnosed with COPD, 30%\< FEV1 \<80% predicated, or FEV1\>80% and FEV1/FVC \< 0.7
• Discharged from the hospital during the last 3 months due to AECOPD.
• Provision of signed and dated informed consent form.
• Speak, read and understand either Hebrew, Arabic or English.
• Able to understand study requirements and comply with study procedures.
• Able to operate a tablet for SG measurement.

You may not qualify if:

• Suffer from any physical or cognitive impairment that may affect subject's capability to operate the SG device properly.
• Pregnant woman or nursing mother.
• Severely ill with less than 12-month life expectancy
• Suffering from serious uncontrolled medical conditions that may interfere with study requirements.
• Participated in another clinical study during the study period, that may interrupt their participation in this study.

Sponsors & Collaborators

• NanoVation: lead

Study Sites (6)

The Barzilai University Medical Center

Ashkelon, Israel

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Rambam Health Campus

Haifa, Israel

Location

Nazareth Hospital E.M.M.S

Nazareth, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

The Institute of Pulmonology Baruch Padeh Medical Center

Tiberias, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saleh Nazzal, Dr.

  Poria Medical Center, Israel

  PRINCIPAL INVESTIGATOR

• Yaniv Dotan, Dr.

  Rambam Health Campus, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All subjects will receive the Investigational device - SenseGuard for daily measurement of respiratory parameters.

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: November 11, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

IL (6)