COPDNCT05865184
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
An observational study of COPD and Chronic Obstructive Pulmonary Disease, run by Sensorum Health Inc. at 1 site in United States.
Trial summary
Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease, COPD Exacerbation
- What is being tested?
- Data collection
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2022to 6 Jun 2024
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted as inpatient to Jersey Shore University Medical Center
Who may be able to join
- Aged 65 years or older
- Able to consent
- Documented history of diagnosis of chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF)
- Currently admitted to JSUMC for observation or as an inpatient with any diagnosis ≥1 prior hospital utilization events with any diagnosis (inpatient admissions, facility observation stays, or ED visits) in the past 12 months
Who cannot join
- Significant cardiac valvular disease
- End-Stage Renal Disease (ESRD)
- End-Stage CHF
- End-Stage COPD
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jersey Shore University Medical Center, Hackensack Meridian Health
Neptune City, New Jersey, 07753
Tracy Micalizzi, 551-238-3488, tracy.micalizzi@hmhn.org
Swapnel Patel, MD
About this study
Official title: Feasibility of Home-based, Ambient Passive Sensor Technology to Provide Early Warning of Health Decompensation by Detecting Deviations in Activities of Daily Living (ADLs) of Elderly Subjects With Diagnosed Chronic Disease
Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease, COPD Exacerbation, CHF, Congestive Heart Failure
- Being tested
- Data collection
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection of clinically relevant signals using home-based sensor system
| Study group | Role | What they receive |
|---|---|---|
| Passive monitoring | No intervention Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall of AI in passive sensor system
Evaluation of AI ability to prospectively detect hospital utilization event
Measured: 90 days
Precision of AI in passive sensor system
Evaluation of AI ability to precisely predict hospital utilization event
Measured: 90 days
Secondary outcomes (2)
Recall of sensor data review by trained nurses
Evaluation of nurse ability to prospectively detect hospital utilization event
Measured: 90 days
Precision of sensor data review by trained nurses
Evaluation of nurse ability to precisely predict hospital utilization event
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start28 Sep 2022
- Primary completion6 Jun 2024 (estimated)
- Study completion6 Jun 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sensorum Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Swapnel Patel, MD, Principal investigator, Jersey Shore University Medical Center, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865184
- Sponsor's protocol ID
- Sensorum P-001
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home-based, Ambient Passive Sensor Technology to Provide Early Warning of Health Decompensation by Detecting Deviations in Activities of Daily Living (ADLs) of Elderly Subjects With Diagnosed Chronic Disease
- ClinicalTrials.gov ID
- NCT05865184
- Acronym / sponsor ID
- Sensorum P-001
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease, COPD Exacerbation, CHF, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sensorum Health Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 6 Jun 2024 (estimated)
- Study completion
- 6 Jun 2024 (estimated)
- First posted
- 18 May 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.
Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Passive monitoring | – | Other: Data collectionNo intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted as inpatient to Jersey Shore University Medical Center
Key inclusion criteria (4 listed)
- Aged 65 years or older
- Able to consent
- Documented history of diagnosis of chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF)
- Currently admitted to JSUMC for observation or as an inpatient with any diagnosis ≥1 prior hospital utilization events with any diagnosis (inpatient admissions, facility observation stays, or ED visits) in the past 12 months
Key exclusion criteria (4 listed)
- Significant cardiac valvular disease
- End-Stage Renal Disease (ESRD)
- End-Stage CHF
- End-Stage COPD
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 |
|---|---|---|
| Data collectionData collection of clinically relevant signals using home-based sensor system | Other | Passive monitoring |
Primary outcome
Recall of AI in passive sensor system
Time frame: 90 days
Evaluation of AI ability to prospectively detect hospital utilization event
Precision of AI in passive sensor system
Time frame: 90 days
Evaluation of AI ability to precisely predict hospital utilization event
2 secondary outcomes
Recall of sensor data review by trained nurses
Time frame: 90 days
Precision of sensor data review by trained nurses
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- 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.
Swapnel Patel, MD principal investigator
Jersey Shore University Medical Center, Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Chronic Obstructive Pulmonary Disease, run by Sensorum Health Inc. at 1 site in United States.
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 4 inclusion and 4 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 18 May 2023. 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 States. 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?
Contact Christine Fernandez ((973) 786-3573, christine@sensorum.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall of AI in passive sensor system (time frame: 90 days). The study lists 2 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 18 May 2023.