COPDNCT06798688
In This Study, the Sponsor Would Like to Collaborate with Institution and Investigator to Aggregate Participants Data and to Pilot Its Software Algorithm Using Machine Learning and Threshold Based Methods for Predicting Exacerbations and Deterioration Within a 60 Days Period Post-discharge
An observational study of COPD, run by Respiree Pte Ltd.
Trial summary
In this study, the sponsor would like to collaborate with Institution and Investigator to aggregate participants data and to pilot its software algorithm using machine learning and threshold based methods for predicting exacerbations and deterioration within a 60 days period post-discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- A non-invasive cardio-respiratory sensor will be applied on the subjects to measure parameters to identify exacerbations
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The enrolment goal is 20 participants with at least 2 documented exacerbations in the past 12 months for a period of 8 weeks each. In addition to the baseline visit and Study on-boarding, there will be 2 follow-ups every month. Participants will be enrolled at discharge (and not designate hospital or ED).
Who may be able to join
- Subject age 18 or older
- Receives all primary and specialty care at Institution
- Participants will be enrolled at discharge (and not designate hospital or ED)
- A history of one of the following diagnoses:
- c. Chronic obstructive pulmonary disease
- At least two documented exacerbations of the above disease in the past 12 months as defined by the following corresponding criteria:
Show all 9Show fewer
- Chronic obstructive pulmonary disease exacerbation: all three of (1) increase in frequency and severity or severity of cough, (2) increase in volume and/or change of character of sputum production, and (3) increase in dyspnea, and requiring treatment with short-acting bronchodilators, antibiotics, and oral or intravenous glucocorticoids.
- Participants able to provide informed consent.
- Participants will be enrolled at discharge (and not designate hospital or ED)
Who cannot join
- Participants with neuromuscular diseases and seizures
- Participants enrolled in hospice care or life expectancy less than three months.
- Participants living more than 60 miles away from Institution and Investigator
- Participants with expected out of state travel within a 30-day period or travel to a location with no internet access.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Software Algorithm Using Machine Learning and Threshold Based Methods for Predicting Exacerbations and Deterioration
In this study, the sponsor would like to collaborate with Institution and Investigator to aggregate participants data and to pilot its software algorithm using machine learning and threshold based methods for predicting exacerbations and deterioration within a 60 days period post-discharge.
- Conditions
- COPD
- Being tested
- A non-invasive cardio-respiratory sensor will be applied on the subjects to measure parameters to identify exacerbations
- 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.
A non-invasive cardio-respiratory sensor will be applied on the subjects to measure parameters to identify exacerbationsDevice
This Study aims to pilot software algorithms based on respiratory features and hemodynamics for predicting exacerbations on a total of 20 participants with COPD. The end-points of this Study includes the following:
- To validate respiratory-based biomarkers in models to predict exacerbations - benchmarking to be done versus physician assess exacerbations, emergency department visits, hospitalizations and any other visit.
- To validate level of compliance, drop-out rate and if additional measures are required to get participants to follow-on
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying readmissions using respiratory biomarkers
To validate respiratory-based biomarkers in models to predict exacerbations - benchmarking to be done versus physician assess exacerbations, emergency department visits, hospitalizations and any other visit.
Measured: 60-days
Secondary outcomes (1)
Validate compliance and usability
To validate level of usability using self-assessed questionnaires required to get participants to follow-on
Measured: 60-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Respiree Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798688
- Sponsor's protocol ID
- 2025-001
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Software Algorithm Using Machine Learning and Threshold Based Methods for Predicting Exacerbations and Deterioration
- ClinicalTrials.gov ID
- NCT06798688
- Acronym / sponsor ID
- 2025-001
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Respiree Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 29 Jan 2025 (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.
In this study, the sponsor would like to collaborate with Institution and Investigator to aggregate participants data and to pilot its software algorithm using machine learning and threshold based methods for predicting exacerbations and deterioration within a 60 days period post-discharge.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The enrolment goal is 20 participants with at least 2 documented exacerbations in the past 12 months for a period of 8 weeks each. In addition to the baseline visit and Study on-boarding, there will be 2 follow-ups every month. Participants will be enrolled at discharge (and not designate hospital or ED).
Key inclusion criteria (9 listed)
- Subject age 18 or older
- Receives all primary and specialty care at Institution
- Participants will be enrolled at discharge (and not designate hospital or ED)
- A history of one of the following diagnoses:
- At least two documented exacerbations of the above disease in the past 12 months as defined by the following corresponding criteria:
Key exclusion criteria (4 listed)
- Participants with neuromuscular diseases and seizures
- Participants enrolled in hospice care or life expectancy less than three months.
- Participants living more than 60 miles away from Institution and Investigator
- Participants with expected out of state travel within a 30-day period or travel to a location with no internet access.
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 |
|---|---|---|
| A non-invasive cardio-respiratory sensor will be applied on the subjects to measure parameters to identify exacerbationsThis Study aims to pilot software algorithms based on respiratory features and hemodynamics for predicting exacerbations on a total of 20 participants with COPD. The end-points of this Study includes the following: 1. To validate respiratory-based biomarkers in models to predict exacerbations - benchmarking to be done versus physician assess exacerbations, emergency department visits, hospitalizations and any other visit. 2. To validate level of compliance, drop-out rate and if additional measures are required to get participants to follow-on | Device | – |
Primary outcome
Identifying readmissions using respiratory biomarkers
Time frame: 60-days
To validate respiratory-based biomarkers in models to predict exacerbations - benchmarking to be done versus physician assess exacerbations, emergency department visits, hospitalizations and any other visit.
1 secondary outcome
Validate compliance and usability
Time frame: 60-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Respiree Pte Ltd.
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 9 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: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gurpreet Singh Singh (6590617570, gurpreet@respiree.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying readmissions using respiratory biomarkers (time frame: 60-days). 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 29 Jan 2025.