Chronic Obstructive Pulmonary Disease (COPD)NCT05119374
Clinical Evaluation of SenseGuard™ to Detect Respiratory Changes, During Home Monitoring of Subjects With High Risk of AECOPD.
A study testing SenseGuard Investigational Device in people with Chronic Obstructive Pulmonary Disease (COPD), run by NanoVation at 6 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- SenseGuard Investigational Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 6 sitesIsrael
- Study dates
- 11 Nov 2021to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Israel6 sites
The Barzilai University Medical Center
Ashkelon
Bnai Zion Medical Center
Haifa
Rambam Health Campus
Haifa
Nazareth Hospital E.M.M.S
Nazareth
Tel Aviv Medical Center
Tel Aviv
The Institute of Pulmonology Baruch Padeh Medical Center
Tiberias
About this study
Official title: Clinical Evaluation of the Capability of SenseGuard™ Non-invasive Wearable Device, to Detect Respiratory Changes, During Home Monitoring of Subjects With High Susceptibility for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
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.
Read the 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.
- Being tested
- SenseGuard Investigational Device
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenseGuard Investigational DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigational SenseGuard Device | Experimental | All subjects use SenseGuard Device for twice daily monitoring of respiratory parameters. Receives: Device: SenseGuard Investigational Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start11 Nov 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive the Investigational device - SenseGuard for daily measurement of respiratory parameters.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoVation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saleh Nazzal, Dr., Principal investigator, Poria Medical Center, IsraelYaniv Dotan, Dr., Principal investigator, Rambam Health Campus, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119374
- Sponsor's protocol ID
- PD-CLN-003
- Status last verified
- Mar 2024
- First submitted
- 3 Nov 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Capability of SenseGuard™ Non-invasive Wearable Device, to Detect Respiratory Changes, During Home Monitoring of Subjects With High Susceptibility for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
- ClinicalTrials.gov ID
- NCT05119374
- Acronym / sponsor ID
- PD-CLN-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- NanoVationIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive the Investigational device - SenseGuard for daily measurement of respiratory parameters.
| Arm | Type | Receives |
|---|---|---|
| Investigational SenseGuard Device | Experimental | Device: SenseGuard Investigational DeviceAll subjects use SenseGuard Device for twice daily monitoring of respiratory parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SenseGuard Investigational DeviceSG 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. | Device | Investigational SenseGuard Device |
Primary outcome
Significant changes in SenseGuard device respiratory parameters (Ratio of Inhalation to exhalation time) can indicate for early exacerbation of COPD patient.
Time frame: 6 months
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).
1 secondary outcome
Rate of retention and Compliance of COPD patients who use SG for home monitoring
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saleh Nazzal, Dr. principal investigator
Poria Medical Center, Israel
Yaniv Dotan, Dr. principal investigator
Rambam Health Campus, Haifa, Israel
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenseGuard Investigational Device in people with Chronic Obstructive Pulmonary Disease (COPD), run by NanoVation at 6 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant changes in SenseGuard device respiratory parameters (Ratio of Inhalation to exhalation time) can indicate for early exacerbation of COPD patient. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.