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

NCT ID: NCT05119374

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2024-02-28

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.

Detailed Description

During the study subject will be monitored daily for up to 6 months. Subject will perform 2 daily measurements of tidal breathing with SG, for 8 minutes each. Measurements are performed at the same time window every day; in the morning, before any treatment, and in the evening.

Monitoring will be continued during exacerbations and hospitalization if and when occurred.

Subject will complete a weekly online COPD symptoms assessment questionnaire, sent by email or a text massage.

Subject will report the clinical team about any increase of respiratory symptoms that may lead to exacerbation. Subject will get treatment for confirmed exacerbation according to the Standard of Care. Each case of symptoms and/or confirmed exacerbation will be documented in the CRF and reported to NanoVation team within 24 hours from onset. The daily data obtained by SG, prior to the exacerbation, will be analyzed to detect early respiratory change associated with this exacerbation. This information is critical for SG data interpretation and for the development of early alert for AECOPD.

NanoVation team will provide all subjects with the following: training to use SG, technical support in any case of a problem with the device and reminders to use the SG in case of reduced compliance.

Study will include 3 visits:

Visit 1 - Enrolment visit (Day 0): will be conducted during subject hospitalization or at discharge day, or by inviting eligible subjects to this visit (subjects who were hospitalized during the last 3 months due to AECOPD).

Enrolment of eligible subjects by the clinical team will include:

• Review of medical record and diagnosis.
• Evaluation of Inclusion/ exclusion criteria.
• Subject receives explanation about study.
• Subject signs the Informed Consent form (ICF).
• Subject performs baseline Spirometry test.
• Subject fills a baseline COPD symptoms assessment questionnaire (CSAQ).
• Next visits are scheduled.
• Subject receives the SG home kit
• Subject is trained for self-operation of SG measurement.
• Subject's data is documented in the CRF.

Visit 2- Follow up visit (at 3 months) Subject will have a routine clinical follow up 3 months after discharge and recruitment to the study. During this visit, subject will undergo a routine spirometry breathing test and complete a usability questionnaire evaluating the daily experience with SG measurement. All data will be documented in the CRF.

Visit 3- End of study visit (at 6 months) Subject will have a routine clinical follow up, Subject will undergo a routine spirometry breathing test and will complete a SG usability questionnaire. Subject will return the SG home kit and all data will be documented in the CRF.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Investigational SenseGuard Device

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

Group Type: EXPERIMENTAL

SenseGuard Investigational Device

Intervention Type: 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.

Interventions

SenseGuard Investigational 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged ≥18.

2. Diagnosed with COPD, 30%< FEV1 <80% predicated, or FEV1>80% and FEV1/FVC < 0.7

3. Discharged from the hospital during the last 3 months due to AECOPD.

4. Provision of signed and dated informed consent form.

5. Speak, read and understand either Hebrew, Arabic or English.

6. Able to understand study requirements and comply with study procedures.

7. Able to operate a tablet for SG measurement.

Exclusion Criteria

1. Suffer from any physical or cognitive impairment that may affect subject's capability to operate the SG device properly.

2. Pregnant woman or nursing mother.

3. Severely ill with less than 12-month life expectancy

4. Suffering from serious uncontrolled medical conditions that may interfere with study requirements.

5. Participated in another clinical study during the study period, that may interrupt their participation in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NanoVation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saleh Nazzal, Dr.

Role: PRINCIPAL_INVESTIGATOR

Poria Medical Center, Israel

Yaniv Dotan, Dr.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Campus, Haifa, Israel

Locations

The Barzilai University Medical Center

Ashkelon, , Israel

Bnai Zion Medical Center

Haifa, , Israel

Rambam Health Campus

Haifa, , Israel

Nazareth Hospital E.M.M.S

Nazareth, , Israel

Tel Aviv Medical Center

Tel Aviv, , Israel

The Institute of Pulmonology Baruch Padeh Medical Center

Tiberias, , Israel

Countries

Israel

Other Identifiers

PD-CLN-003

Identifier Type: -

Identifier Source: org_study_id