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This is an observational, open labeled study. The study aims to evaluate the capability of SenseGuardâ„¢ (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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational SenseGuard Device | Experimental | All subjects use SenseGuard Device for twice daily monitoring of respiratory parameters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 SenseGuardâ„¢ (significant change from baseline of Ratio of Inhalation to Exhalation time). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of retention and Compliance of COPD patients who use SG for home monitoring | At least 60% of subjects completed at least 1 month of home monitoring by SG and were compliant to the study protocol. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saleh Nazzal, Dr. | Poria Medical Center, Israel | Principal Investigator |
| Yaniv Dotan, Dr. | Rambam Health Campus, Haifa, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Barzilai University Medical Center | Ashkelon | Israel | ||||
| Bnai Zion Medical Center |
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All subjects will receive the Investigational device - SenseGuard for daily measurement of respiratory parameters.
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|
| 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 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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