Covid19REMAP-WEST-COVNCT04695821
Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology in Covid-19
A study testing Senti V1.0 Device in people with Covid19, run by Senti Tech Ltd at 1 site in United Kingdom.
Trial summary
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for autonomously monitoring of breath and heart sounds in Covid-19 (detecting and monitoring the progression of Covid-19 pneumonitis, by evaluating sounds captured through a wearable device (Senti)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Senti V1.0 Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2021to Mar 2021
- 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
- Patients attending A\&E with Covid-19 or suspected Covid-19, who are being discharged from A\&E into the community.
Who cannot join
- Patients unable to give their consent.
- Patients with a known sensitivity or allergy to any of the components of the device.
- Patients with any active implanted devices (such as pacemakers or vagal nerve stimulators).
- Patients with existing pressure sores across the area this device would come into contact (predominantly, across the thorax).
- Patients with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own ADLs; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Small-scale Study to Capture Acoustic Pathophysiological Parameters, in the Community, Through a Wearable Device, and to Evaluate the Technical and Practical Feasibility of Utilising This Data as Part of a Medical Device System for the Monitoring and Evaluation of Covid-19 at Home
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for autonomously monitoring of breath and heart sounds in Covid-19 (detecting and monitoring the progression of Covid-19 pneumonitis, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. Healthcare resources have been stretched substantially by Covid-19. Devices which enable patients to be monitored at home and direct these precious resources to those who require them are needed more than ever.
10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A\&E into the community, with Covid-19. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions:
Read more
What is the feasibility of the Senti data-capture device? Is this device usable in clinical practice? What are the requirements to train patients to use the device?
The investigators will also consider:
Does the device function technically and practically, in real-world clinical scenarios? What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores)?
These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals for Covid-19.
Read the detailed description
TITLE: Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters with external sensor technology in Covid-19.
DESIGN: First-In-Man and Feasibility study of the Senti Version 1 Device in Covid-19.
AIMS: To explore the acceptability and feasibility of a novel medical device for the remote monitoring and evaluation of acoustic pathophysiological parameters in Covid-19. To investigate usability and acceptability of the Senti data capture device, and to ensure technical and practical functionality of the device in a real-world clinical scenario.
PRIMARY OUTCOMES: Device feasibility SECONDARY OUTCOMES: Length of time with the device in situ. The ease with which patients can apply the device.
POPULATION ELIGIBILITY: Patients with covid-19 or suspected of having Covid-19 clinically, being discharged home into the community after attending A\&E.
DURATION: 3 Months. (Recruitment period: 2 months. Analysis and reporting: 1 month).
- Conditions
- Covid19
- Being tested
- Senti V1.0 Device
- Keywords
- medical device, remote monitoring
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senti V1.0 DeviceDevice
This device class I, CE marked garment, with a similar form to a T-Shirt, embedded with ten sensor modules encased in silicone; the device comes with a charging stand in the form of a clothes hanger. Depending on the outcome of this feasibility study, the device may, in the future, form part of a class IIb medical device system, when accompanied by cloud-based software to listen to both current and historically recorded breath sounds for each Senti patient. The Senti Version One device will be labelled clearly to indicate the device version, on the inside of the garment, conforming to the MDR.
The garment itself will be made from textile composite, including cotton, elastase, micromodel, spandex, and polyester. All other components (including electronic and other plastic components) will be entirely encased in medical-grade silicone.
| Study group | Role | What they receive |
|---|---|---|
| Senti Arm | Experimental | In stage 1 of this study (6 patients), the patient will apply the device and complete the initial patient survey; questions are around usability, comfort (including feelings of pressure), and acceptability. The Investigator will record the time taken to apply the device. A brief 30 seconds of chest sounds will be recorded from each of the nine sensors on the device in three different settings: standing up, lying down, walking around.
In stage 2 of this study (10 patients; 6 of whom would be re-recruited from the first stage), the participant will use the device at home over five days. The Investigator will assess the participant daily for any signs of pressure sores or complications from using the device (including topical allergic reactions). The participant will complete a daily survey. The participant is encouraged to remove the device and apply it at their discretion. The participant can opt-out of wearing the device at any stage. Receives: Device: Senti V1.0 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated device acceptability
Patient questionnaire "on a scale of 1 ("I would not approve at all") to 5 ("I would greatly approve and would like this to become standard practice"), to what extent would you approve of this device being used to enable clinicians to assess your heart and lung sounds as part of a telephone consultation?"
Measured: 1 month
Patient-rated device comfort
Patient questionnaire "on a scale of 1 ("Very difficult to use") to 5 ("Very easy to use"), how easy to use is the device?"
Measured: 1 month
Patient-rated device ease of use
Patient questionnaire "on a scale of 1 ("Too uncomfortable to use for more than an hours or so") to 5 ("As comfortable as a T-Shirt"), how comfortable is the device?"
Measured: 1 month
Expert-rated device data quality
An appropriately qualified person (with clinical experience of auscultation) to rate quality of data captured by the device, as compared subjectively against the quality that they typically expect from standard auscultation, on a scale of 1 ("Much poorer data quality [than standard auscultation]") to 3 ("equivocal data quality") to 5 ("Much higher data quality").
Measured: 1 month
Adverse events and adverse device events
The number of participants experiencing adverse events, both arising from use of the device or otherwise, will be reported. Adverse events will be categorised as unexpected or expected, serious or otherwise, device-related or un-related.
Measured: 1 month
Secondary outcomes (4)
Length of time spent with the device on the patient.
Length of time over which a patient has used the device, as measured using a structured, binned multiple-choice survey. This is a custom-made scale titled "In the past 24 hours, for how many hours have you worn the Senti device?" with a minimum value of 0 hours and a maximum value of 24 hours. 8 options which include a range of times are available for selection.
Measured: 1 month
Length of time taken for the patient to apply the device
Length of time taken for the patient to put the device on, as measured by an investigator with a stop watch.
Measured: 1 month
Time spent to train patients to use the device.
Length of time taken to train patients to use the device, as measured by an investigator with a stop watch.
Measured: 1 month
Pressure sore EPUAP grade
For those patients who develop pressure sores, the pressure sore will be graded using the European Pressure Ulcer Advisory Panel grading system from a grade of grade 1 through to grade 4, including unclassified gradings and moisture lesions. (Patients will be graded as "No pressure sores" if there are no pressure sores noted on examination).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A pilot stage, exploratory, First-In-Human and traditional feasibility, interventional study of the Senti V1.0 device (CE marked, Class I device), involving 10 patients attending A\&E with or suspected to have Covid-19, who are being discharged into the community. 5 devices will be used, to cover a range of sizes from extra-small to extra-large.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senti Tech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695821
- Sponsor's protocol ID
- Senti-REMAP-WEST-COV-1
- Acronym
- REMAP-WEST-COV
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Small-scale Study to Capture Acoustic Pathophysiological Parameters, in the Community, Through a Wearable Device, and to Evaluate the Technical and Practical Feasibility of Utilising This Data as Part of a Medical Device System for the Monitoring and Evaluation of Covid-19 at Home
- ClinicalTrials.gov ID
- NCT04695821
- Acronym / sponsor ID
- REMAP-WEST-COV / Senti-REMAP-WEST-COV-1
- Conditions
- Covid19
- Keywords
- medical device, remote monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Senti Tech LtdIndustry (pharma, biotech, devices)
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- Jan 2021 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 5 Jan 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.
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for autonomously monitoring of breath and heart sounds in Covid-19 (detecting and monitoring the progression of Covid-19 pneumonitis, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting. Healthcare resources have been stretched substantially by Covid-19. Devices which enable patients to be monitored at home and direct these precious resources to those who require them are needed more than ever.
10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A\&E into the community, with Covid-19. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions:
What is the feasibility of the Senti data-capture device? Is this device usable in clinical practice? What are the requirements to train patients to use the device?
The investigators will also consider:
Does the device function technically and practically, in real-world clinical scenarios? What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores)?
These questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals for Covid-19.
Detailed description
TITLE: Remote Evaluation and Monitoring of Acoustic Pathophysiological parameters with external sensor technology in Covid-19.
DESIGN: First-In-Man and Feasibility study of the Senti Version 1 Device in Covid-19.
AIMS: To explore the acceptability and feasibility of a novel medical device for the remote monitoring and evaluation of acoustic pathophysiological parameters in Covid-19. To investigate usability and acceptability of the Senti data capture device, and to ensure technical and practical functionality of the device in a real-world clinical scenario.
PRIMARY OUTCOMES: Device feasibility SECONDARY OUTCOMES: Length of time with the device in situ. The ease with which patients can apply the device.
POPULATION ELIGIBILITY: Patients with covid-19 or suspected of having Covid-19 clinically, being discharged home into the community after attending A\&E.
DURATION: 3 Months. (Recruitment period: 2 months. Analysis and reporting: 1 month).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pilot stage, exploratory, First-In-Human and traditional feasibility, interventional study of the Senti V1.0 device (CE marked, Class I device), involving 10 patients attending A\&E with or suspected to have Covid-19, who are being discharged into the community. 5 devices will be used, to cover a range of sizes from extra-small to extra-large.
| Arm | Type | Receives |
|---|---|---|
| Senti Arm | Experimental | Device: Senti V1.0 DeviceIn stage 1 of this study (6 patients), the patient will apply the device and complete the initial patient survey; questions are around usability, comfort (including feelings of pressure), and acceptability. The Investigator will record the time taken to apply the device. A brief 30 seconds of chest sounds will be recorded from each of the nine sensors on the device in three different settings: standing up, lying down, walking around. In stage 2 of this study (10 patients; 6 of whom would be re-recruited from the first stage), the participant will use the device at home over five days. The Investigator will assess the participant daily for any signs of pressure sores or complications from using the device (including topical allergic reactions). The participant will complete a daily survey. The participant is encouraged to remove the device and apply it at their discretion. The participant can opt-out of wearing the device at any stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients attending A\&E with Covid-19 or suspected Covid-19, who are being discharged from A\&E into the community.
Key exclusion criteria (5 listed)
- Patients unable to give their consent.
- Patients with a known sensitivity or allergy to any of the components of the device.
- Patients with any active implanted devices (such as pacemakers or vagal nerve stimulators).
- Patients with existing pressure sores across the area this device would come into contact (predominantly, across the thorax).
- Patients with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own ADLs; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).
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 V1.0 DeviceThis device class I, CE marked garment, with a similar form to a T-Shirt, embedded with ten sensor modules encased in silicone; the device comes with a charging stand in the form of a clothes hanger. Depending on the outcome of this feasibility study, the device may, in the future, form part of a class IIb medical device system, when accompanied by cloud-based software to listen to both current and historically recorded breath sounds for each Senti patient. The Senti Version One device will be labelled clearly to indicate the device version, on the inside of the garment, conforming to the MDR. The garment itself will be made from textile composite, including cotton, elastase, micromodel, spandex, and polyester. All other components (including electronic and other plastic components) will be entirely encased in medical-grade silicone. | Device | Senti Arm |
Primary outcome
Patient-rated device acceptability
Time frame: 1 month
Patient questionnaire "on a scale of 1 ("I would not approve at all") to 5 ("I would greatly approve and would like this to become standard practice"), to what extent would you approve of this device being used to enable clinicians to assess your heart and lung sounds as part of a telephone consultation?"
Patient-rated device comfort
Time frame: 1 month
Patient questionnaire "on a scale of 1 ("Very difficult to use") to 5 ("Very easy to use"), how easy to use is the device?"
Patient-rated device ease of use
Time frame: 1 month
Patient questionnaire "on a scale of 1 ("Too uncomfortable to use for more than an hours or so") to 5 ("As comfortable as a T-Shirt"), how comfortable is the device?"
Expert-rated device data quality
Time frame: 1 month
An appropriately qualified person (with clinical experience of auscultation) to rate quality of data captured by the device, as compared subjectively against the quality that they typically expect from standard auscultation, on a scale of 1 ("Much poorer data quality [than standard auscultation]") to 3 ("equivocal data quality") to 5 ("Much higher data quality").
Adverse events and adverse device events
Time frame: 1 month
The number of participants experiencing adverse events, both arising from use of the device or otherwise, will be reported. Adverse events will be categorised as unexpected or expected, serious or otherwise, device-related or un-related.
4 secondary outcomes
Length of time spent with the device on the patient.
Time frame: 1 month
Length of time taken for the patient to apply the device
Time frame: 1 month
Time spent to train patients to use the device.
Time frame: 1 month
Pressure sore EPUAP grade
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 V1.0 Device in people with Covid19, 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 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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?
Results are not available in the source record.
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?
Patient-rated device acceptability (time frame: 1 month). The study lists 5 primary outcomes in all. 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 5 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.