COPD ExacerbationNCT07554352
Early Detection of COPD Exacerbations Using Home Monitoring Device
An observational study of COPD Exacerbation, run by RespirAI US Inc at 1 site in United States.
Trial summary
The goal of this observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age >21) with physician-diagnosed COPD who are at high risk for exacerbations. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- RespirAI
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to May 2027
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 21 and older with physician-diagnosed COPD who are at high risk for exacerbations.
Who may be able to join
- Age >21 years.
- Physician-diagnosed COPD at least 6 months prior to screening visit.
- Two or more moderate COPD exacerbations in the past 6 months or 1 severe exacerbation during the past 6 months.
- Free of exacerbation for 1 month before enrollment.
Who cannot join
- Unable or willing to sign an informed consent.
- Unable to complete the 6-minute walk test due to physical or mental health conditions.
- Patients with cardiac pacemaker, defibrillators, or other implanted electronic devices.
- Pregnancy
- Study clinician determines that the patient is unable or unwilling to comply with all study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Methodist Physicians Clinic
Omaha, Nebraska, 68114
DruAnne H McMartin, CCRC, MA, 402-354-0350, dru.mcmartin@nmhs.org
Rebecca A Van Winkle, RN, BSN, (402) 354-0350, rebecca.vanwinkle@nmhs.org
About this study
Official title: A Multi-center, Observational Prospective Clinical Study to Evaluate the Safety and Effectiveness of a Home - Monitoring COPD Management Software for Early Detection of Exacerbations.
The goal of this observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age >21) with physician-diagnosed COPD who are at high risk for exacerbations. The study will collect data from participants with COPD that will be analyzed using an AI-based algorithm to predict exacerbation events. The device's predictions will then be compared against clinically documented exacerbations to assess detection accuracy.
- Conditions
- COPD Exacerbation
- Being tested
- RespirAI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespirAIDevice
Use of a software-based monitoring device for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| High risk COPD patients | Adults aged 21 years and older with physician-diagnosed COPD who are at high risk for exacerbations, wearing a study device for 6 months. Receives: Device: RespirAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Percentage of clinically verified moderate or severe COPD exacerbation events detected by the device
Measured: 6 months
False alam rate
The rate of false alarms produced by the device.
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 posted28 Apr 2026
- Study start5 Aug 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RespirAI US Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam D Wells, MD, FCCP, Principal investigator, Nebraska Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554352
- Sponsor's protocol ID
- CL-020
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 10 Aug 2026
- 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Observational Prospective Clinical Study to Evaluate the Safety and Effectiveness of a Home - Monitoring COPD Management Software for Early Detection of Exacerbations.
- ClinicalTrials.gov ID
- NCT07554352
- Acronym / sponsor ID
- CL-020
- Conditions
- COPD Exacerbation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RespirAI US IncIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Apr 2026 (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 observational study is to evaluate the safety and effectiveness of a home-monitoring device (RespirAI) in the early detection of COPD exacerbations in adults (age >21) with physician-diagnosed COPD who are at high risk for exacerbations. The study will collect data from participants with COPD that will be analyzed using an AI-based algorithm to predict exacerbation events. The device's predictions will then be compared against clinically documented exacerbations to assess detection accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk COPD patients | – | Device: RespirAIAdults aged 21 years and older with physician-diagnosed COPD who are at high risk for exacerbations, wearing a study device for 6 months. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 21 and older with physician-diagnosed COPD who are at high risk for exacerbations.
Key inclusion criteria (4 listed)
- Age >21 years.
- Physician-diagnosed COPD at least 6 months prior to screening visit.
- Two or more moderate COPD exacerbations in the past 6 months or 1 severe exacerbation during the past 6 months.
- Free of exacerbation for 1 month before enrollment.
Key exclusion criteria (5 listed)
- Unable or willing to sign an informed consent.
- Unable to complete the 6-minute walk test due to physical or mental health conditions.
- Patients with cardiac pacemaker, defibrillators, or other implanted electronic devices.
- Pregnancy
- Study clinician determines that the patient is unable or unwilling to comply with all study procedures.
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 |
|---|---|---|
| RespirAIUse of a software-based monitoring device for 6 months. | Device | High risk COPD patients |
Primary outcome
Sensitivity
Time frame: 6 months
Percentage of clinically verified moderate or severe COPD exacerbation events detected by the device
False alam rate
Time frame: 6 months
The rate of false alarms produced by the device.
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 10 Aug 2026.
- 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.
Adam D Wells, MD, FCCP principal investigator
Nebraska Methodist Hospital
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 Exacerbation, run by RespirAI US 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 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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?
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 Tamar Sobol ((617) 615-6799, info@respriai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 6 months). 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 10 Aug 2026.