COPDREMAPWESTFLARENCT05745155
REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation
A study testing Senti Wear device system with Senti-AI subsystem in people with COPD, run by Senti Tech Ltd at 1 site in United Kingdom.
Trial summary
The goal of this clinical investigation is to explore the efficacy and economics of a novel medical device system which, through the remote monitoring and evaluation of acoustic pathophysiological parameters in long-term respiratory conditions, flags patients who are beginning to deteriorate for clinical review, in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Senti Wear device system with Senti-AI subsystem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2023to 30 Apr 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
- Diagnosis of COPD (on GP record is acceptable) and at least one COPD exacerbation requiring steroid prescription in the last three years
Who cannot join
- Participants with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own Activities of Daily Living; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).
- Participants with existing pressure sores across the thorax and/or torso.
- Participants under the age of 18.
- Participants with a height outside the range (150-189cm)
- Participants with a waist circumference outside the range (62-169cm)
- Participants with a known sensitivity or allergy to any of the components of the device.
- Participants unable to give their consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Senti Remote Evaluation and Monitoring of Acoustic Pathophysiological Parameters with External Sensor Technology - FLAg for Review Efficacy Investigation: a Community-based Double-blinded Comparative Pivotal Clinical Efficacy Study to Investigate the Efficacy and Safety of a Novel Intelligent Wearable Medical Device System for the Autonomous Monitoring and Evaluation of Acoustic Pathophysiological Parameters in Order to Determine Clinical Deterioration and Flag Deteriorating Patients for Clinical Review, Reducing Time-to-intervention in Respiratory Disease Flareups
The goal of this clinical investigation is to explore the efficacy and economics of a novel medical device system which, through the remote monitoring and evaluation of acoustic pathophysiological parameters in long-term respiratory conditions, flags patients who are beginning to deteriorate for clinical review, in order to reduce time-to-intervention in respiratory disease flareups.
The main question it aims to answer are:
Read more
Would the use of the Senti-AI and Senti-Wear Device System reduce time-to-intervention in respiratory disease flareups?
Participants will wear the Senti-Wear device up to twice per day as tolerated for 12 weeks. The Senti-AI subsystem will generate FLAREs (flags for review) and these will retrospectively be compared to the standard of care to evaluate whether acting on the FLARES would have reduced time-to-intervention.
Read the detailed description
This clinical investigation seeks to establish whether or not the Senti-Wear device system with the Senti-AI subsystem is effective for autonomously monitoring people with long-term respiratory illness with COPD. The aim of this autonomous monitoring is to generate flags for review (FLARES) if the system detects a worsening (deterioration) in lung sounds which might indicate a worsening respiratory illness.
If effective, this device system will enable people with long-term respiratory illnesses to receive earlier intervention in disease flare-ups, ensuring these patients are on the right medication at the right time, avoiding hospital admissions, and staying well at home.
200 patients with COPD will be recruited. The design of this study is comparative. All 200 participants will undertake patient-sought care as usual, where patients seek medical aid once starting to feel more unwell. Over a six-month period, we will collect data on what care is sought and when this changes treatment. Participants will also use the Senti-Wear device to capture their breath and heart sounds twice a day over this six-month period. Participants, clinicians, and the research team will be blinded to the device output FLARES until the end of the data collection period.
At the end of the data collection period, we will compare this with Senti-AI FLARES, to determine whether acting on FLARES would have led to early intervention in disease flareups.
The study activities will take place in the participants' own homes. The study will recruit around Manchester and Liverpool, UK. The study is being funded by Senti-Tech limited, the manufacturer of the Senti-Wear with Senti-AI device system.
- Conditions
- COPD
- Being tested
- Senti Wear device system with Senti-AI subsystem
- 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.
Senti Wear device system with Senti-AI subsystemDevice
This device is a smart garment, with a similar form to a T-Shirt, jacket or tabard, embedded with ten sensor modules (nine acoustic sensors, one kinetic sensor - all able to detect signals from the chest wall and underlying structures, including the lungs) encased in silicone; the device is charged via a charging port in the garment. The device has two modes of operation: recording mode and charging mode. The device is internally (battery) powered during recording mode and mains-powered during charging mode. The device is accompanied by cloud-based software to listen to both contemporaneous and historically recorded breath sounds, for each Senti patient. To use the device, the user puts the garment on (overhead, like a T-Shirt, before joining the back piece to the front like a tabard).
Additionally, Senti-AI adds an anomaly burden score and an alert "flag for review" against each acoustic record for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Senti-Wear with Senti-AI | Experimental | Participants will wear the Senti-Wear smart garment up to twice per day (as tolerated) and complete a study journal detailing issues with the device and changes to their respiratory illness. Receives: Device: Senti Wear device system with Senti-AI subsystem |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment
Area under the Receiver Operator Characteristic curve (AUC) for FLAREs at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment being initiated (such as antibiotics/steroids prescription). This outcome measure is clinically meaningful as this metric quantifies the performance of the system for reducing time-to-intervention in respiratory disease flareups by specific time intervals. Earlier intervention in respiratory disease flareups, in turn, will improve outcomes, reduce hospitalisations, and improve quality of life.
Measured: 12 weeks
Secondary outcomes (11)
Average time difference between FLAREs and change in treatment
Average time difference between true-positive FLARE to change in treatment. Change in treatment is defined as antibiotic/steroid/nebuliser acute prescription or change in respiratory preventative medication.
Measured: 12 weeks
FLAREs False Positive Rate
False Positives (Proportion of FLARES where there was no change in care in the following three weeks under the standard of care). As if the false positive rate is too high, then this will increase burden on services through unnecessary clinical reviews.
Measured: 12 weeks
Device utilisation
Cumulative time device was worn and recorded data over. This will provide an idea of device usability, uptake, and churn.
Measured: 12 weeks
Number of A&E attendances
Number of A\&E attendances
Measured: 12 weeks
Number of hospital admissions
Number of hospital admissions
Measured: 12 weeks
Total sum length of stay of any hospital admissions
Total sum length of stay of any hospital admissions
Measured: 12 weeks
Number of GP visits
Number of GP visits
Measured: 12 weeks
Number of specialist respiratory appointments
Number of specialist respiratory appointments
Measured: 12 weeks
Respiratory Symptomology
Correlation between FLARES and change in symptomatology. As this will provide supportive evidence of the algorithm's efficacy.
Measured: 12 weeks
Usability
Technical and usability device-related issues - qualitative thematic reporting of issues reported by users related to operating the device. As this will drive improvements in future generations of the device.
Measured: 12 weeks
ADEs
Adverse device events. As this will quantify the risks associated with use of the device.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start20 May 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This question will be answered by a double-blinded, comparative, device efficacy investigation, comparing the standard of care with a virtual arm simulating care delivered by acting on FLAREs generated by the Senti-AI subsystem.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senti Tech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sundeep Kaul, MB ChB, Principal investigator, Senti Tech Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745155
- Sponsor's protocol ID
- Senti-REMAP-WEST-FLARE- v1.0
- Acronym
- REMAPWESTFLARE
- Status last verified
- Nov 2024
- First submitted
- 7 Feb 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study data for this study is considered commercially sensitive, and we are formulating plans for an independent, larger, multi-site follow-up study (which is likely to make IDP available). However, we are yet to reach a final decision on this.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senti Remote Evaluation and Monitoring of Acoustic Pathophysiological Parameters with External Sensor Technology - FLAg for Review Efficacy Investigation: a Community-based Double-blinded Comparative Pivotal Clinical Efficacy Study to Investigate the Efficacy and Safety of a Novel Intelligent Wearable Medical Device System for the Autonomous Monitoring and Evaluation of Acoustic Pathophysiological Parameters in Order to Determine Clinical Deterioration and Flag Deteriorating Patients for Clinical Review, Reducing Time-to-intervention in Respiratory Disease Flareups
- ClinicalTrials.gov ID
- NCT05745155
- Acronym / sponsor ID
- REMAPWESTFLARE / Senti-REMAP-WEST-FLARE- v1.0
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Senti Tech LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 27 Feb 2023 (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.
The goal of this clinical investigation is to explore the efficacy and economics of a novel medical device system which, through the remote monitoring and evaluation of acoustic pathophysiological parameters in long-term respiratory conditions, flags patients who are beginning to deteriorate for clinical review, in order to reduce time-to-intervention in respiratory disease flareups.
The main question it aims to answer are:
Would the use of the Senti-AI and Senti-Wear Device System reduce time-to-intervention in respiratory disease flareups?
Participants will wear the Senti-Wear device up to twice per day as tolerated for 12 weeks. The Senti-AI subsystem will generate FLAREs (flags for review) and these will retrospectively be compared to the standard of care to evaluate whether acting on the FLARES would have reduced time-to-intervention.
Detailed description
This clinical investigation seeks to establish whether or not the Senti-Wear device system with the Senti-AI subsystem is effective for autonomously monitoring people with long-term respiratory illness with COPD. The aim of this autonomous monitoring is to generate flags for review (FLARES) if the system detects a worsening (deterioration) in lung sounds which might indicate a worsening respiratory illness.
If effective, this device system will enable people with long-term respiratory illnesses to receive earlier intervention in disease flare-ups, ensuring these patients are on the right medication at the right time, avoiding hospital admissions, and staying well at home.
200 patients with COPD will be recruited. The design of this study is comparative. All 200 participants will undertake patient-sought care as usual, where patients seek medical aid once starting to feel more unwell. Over a six-month period, we will collect data on what care is sought and when this changes treatment. Participants will also use the Senti-Wear device to capture their breath and heart sounds twice a day over this six-month period. Participants, clinicians, and the research team will be blinded to the device output FLARES until the end of the data collection period.
At the end of the data collection period, we will compare this with Senti-AI FLARES, to determine whether acting on FLARES would have led to early intervention in disease flareups.
The study activities will take place in the participants' own homes. The study will recruit around Manchester and Liverpool, UK. The study is being funded by Senti-Tech limited, the manufacturer of the Senti-Wear with Senti-AI device system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This question will be answered by a double-blinded, comparative, device efficacy investigation, comparing the standard of care with a virtual arm simulating care delivered by acting on FLAREs generated by the Senti-AI subsystem.
| Arm | Type | Receives |
|---|---|---|
| Senti-Wear with Senti-AI | Experimental | Device: Senti Wear device system with Senti-AI subsystemParticipants will wear the Senti-Wear smart garment up to twice per day (as tolerated) and complete a study journal detailing issues with the device and changes to their respiratory illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of COPD (on GP record is acceptable) and at least one COPD exacerbation requiring steroid prescription in the last three years
Key exclusion criteria (7 listed)
- Participants with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own Activities of Daily Living; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).
- Participants with existing pressure sores across the thorax and/or torso.
- Participants under the age of 18.
- Participants with a height outside the range (150-189cm)
- Participants with a waist circumference outside the range (62-169cm)
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 |
|---|---|---|
| Senti Wear device system with Senti-AI subsystemThis device is a smart garment, with a similar form to a T-Shirt, jacket or tabard, embedded with ten sensor modules (nine acoustic sensors, one kinetic sensor - all able to detect signals from the chest wall and underlying structures, including the lungs) encased in silicone; the device is charged via a charging port in the garment. The device has two modes of operation: recording mode and charging mode. The device is internally (battery) powered during recording mode and mains-powered during charging mode. The device is accompanied by cloud-based software to listen to both contemporaneous and historically recorded breath sounds, for each Senti patient. To use the device, the user puts the garment on (overhead, like a T-Shirt, before joining the back piece to the front like a tabard). Additionally, Senti-AI adds an anomaly burden score and an alert "flag for review" against each acoustic record for each patient. | Device | Senti-Wear with Senti-AI |
Primary outcome
AUC at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment
Time frame: 12 weeks
Area under the Receiver Operator Characteristic curve (AUC) for FLAREs at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment being initiated (such as antibiotics/steroids prescription). This outcome measure is clinically meaningful as this metric quantifies the performance of the system for reducing time-to-intervention in respiratory disease flareups by specific time intervals. Earlier intervention in respiratory disease flareups, in turn, will improve outcomes, reduce hospitalisations, and improve quality of life.
11 secondary outcomes
Average time difference between FLAREs and change in treatment
Time frame: 12 weeks
FLAREs False Positive Rate
Time frame: 12 weeks
Device utilisation
Time frame: 12 weeks
Number of A&E attendances
Time frame: 12 weeks
Number of hospital admissions
Time frame: 12 weeks
Total sum length of stay of any hospital admissions
Time frame: 12 weeks
Number of GP visits
Time frame: 12 weeks
Number of specialist respiratory appointments
Time frame: 12 weeks
Respiratory Symptomology
Time frame: 12 weeks
Usability
Time frame: 12 weeks
ADEs
Time frame: 12 weeks
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 4 Dec 2024.
- Individual participant dataSharing planned: Undecided. The study data for this study is considered commercially sensitive, and we are formulating plans for an independent, larger, multi-site follow-up study (which is likely to make IDP available). However, we are yet to reach a final decision on this.
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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.
Sundeep Kaul, MB ChB principal investigator
Senti Tech Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senti Wear device system with Senti-AI subsystem in people with COPD, run by Senti Tech Ltd at 1 site in United Kingdom.
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 1 inclusion and 7 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 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
AUC at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment (time frame: 12 weeks). 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 4 Dec 2024.