CopdNCT04003415
Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients
A study testing Investigational Device: Contactless heart rate and respiratory rate monitor, Heart Rate (EKG) Monitor and Respiratory rate Monitor in people with Copd and Asthma, run by Stanford University at 1 site in United States.
Trial summary
This study will test the accuracy of an investigational, non-invasive device for measuring heart rate and respiratory rate. The device emits radiowaves that allows it to pick up subtle changes in a person's chest wall, which allows it to calculate the heart rate and respiratory rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Copd, Asthma, Respiratory Effort
- What is being tested?
- Investigational Device: Contactless heart rate and respiratory rate monitor, Heart Rate (EKG) Monitor and Respiratory rate Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 20 Sep 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
- Patient seen at the Stanford University Hospital Chest Clinic
- Patient age 18 or older
- Patient able to consent
- Patient with one of the following two medical conditions: Chronic Obstructive Pulmonary - Disease or Asthma
- Participant (or accompanying family / caretaker) able to speak English
Who cannot join
- Patient does not meet inclusion criteria (under age 18, unable to consent, etc.)
- Patient is hospitalized
- Patient is having an acute exacerbation of their respiratory condition
- Patient is having an acute exacerbation of a comorbid condition
- Patient has comorbid cardiac disease, including one of the conditions listed below:
- Arrhythmias (including atrial fibrillation, NSVT, etc.)
Show all 22Show fewer
- Congestive Heart Failure
- Unstable angina
- Myocardial infarction within the last 3 months prior to enrollment
- Uncorrected congenital heart disease
- Uncorrected severe valvular disease
- Pulmonary Hypertension (moderate or higher grade)
- Patient has one of the following conditions:
- Moderate pleural effusion
- Large pleural effusion
- Advanced stage lung cancer (Stage III or Stage IV disease)
- Active infectious process, including viral process or pneumonia
- Interstitial lung disease
- Pleural disease, including pleural malignancies, trapped lung, etc
- Active Cheyne-Stokes respiration
- Patient has baseline increased work of breathing not due to their underlying respiratory disease (ie. COPD or asthma)
- Ongoing substance abuse (not including cigarette use)
Trial locations and contacts
1 site in 1 country.
About this study
This study will test the accuracy of an investigational, non-invasive device for measuring heart rate and respiratory rate. The device emits radiowaves that allows it to pick up subtle changes in a person's chest wall, which allows it to calculate the heart rate and respiratory rate. We propose to study whether the device's measurements are accurate and reproducible in patients with chronic obstructive pulmonary disease (COPD) or asthma. The device undergoing study has been evaluated in healthy volunteers, but its accuracy in vital sign monitoring in patients with respiratory conditions has not yet been established. This study will serve as the foundation for additional work to assess the device's accuracy in measuring a patient's overall "work of breathing" or respiratory effort. Future work will examine the device's accuracy in measuring work of breathing in patients having an exacerbation of their underlying respiratory condition.
The primary aim of this study will be to assess the validity of heart rate and respiratory rate measurements in patients with either COPD or asthma.
- Conditions
- Copd, Asthma, Respiratory Effort, Contactless Vital Sign Monitoring
- Being tested
- Investigational Device: Contactless heart rate and respiratory rate monitor, Heart Rate (EKG) Monitor, Respiratory rate Monitor, Pulse Oximetry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Device: Contactless heart rate and respiratory rate monitorDevice
Also called Investigational Device
Participant will be seated next to the investigational device. The device is contactless, and will measure the patient's heart rate and respiratory rate through use of radio-waves.
Heart Rate (EKG) MonitorDiagnostic test
Participant will undergo 3-lead EKG testing to measure heart rate during testing.
Respiratory rate MonitorDiagnostic test
Participant will have an elastic band around their chest for monitoring respiratory rate during testing.
Pulse OximetryDiagnostic test
Participants will wear a finger pulse oximeter during the testing for monitoring of heart rate, respiratory rate, and pulse oximetry.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device Arm | Experimental | Once consented for the study, participants will undergo testing with the investigational device for a one hour period. Testing will entail the participant wearing an EKG monitor, a respiratory rate monitor, a pulse oximeter, and being positioned next to the investigational device. The investigational device is contactless and captures chest movement of participants which allows it to estimate real time heart rate and respiratory rate. Additional data collected with the EKG monitor, respiratory rate monitor, and the pulse oximeter will be used to validate the vital sign data collected by the investigational device. After data collection is complete, participant involvement will then be over. Participants will have the option to return on a later date for additional testing (up to a maximum of three sessions total), within the six month window of the study. Participants will continue their standard of care therapies for their respiratory condition. Receives: Device: Investigational Device: Contactless heart rate and respiratory rate monitor; Diagnostic Test: Heart Rate (EKG) Monitor; Diagnostic Test: Respiratory rate Monitor; Diagnostic Test: Pulse Oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.
Measured: 30 - 60 minutes
Respiratory rate
Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.
Measured: 30 - 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Mar 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- All participants enrolled in the study will be in the intervention arm. Intervention consists of device feasibility and validation of heart rate and respiratory rate data collected.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Work of Breathing Study Group
- Responsible party
- Principal investigator, Andrea Jonas, Stanford University
- Investigators
- Andrea Jonas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003415
- Sponsor's protocol ID
- IRB-51805
- Status last verified
- Sep 2021
- First submitted
- 26 Jun 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Full Access: Access to Data, Access to patient PHI, Access to RedCap Document linking patients to their study numbers. Limited Access: Access to de-identified participant data for analysis Study PI and Study Faculty Sponsor: Full Access Research Team and Industry Sponsors: Limited Access Upon enrollment each participant will be assigned a unique study number. Any study data collected will be linked to the patient solely through the study number. The document that contains the patient information and their study numbers will by kept on Stanford RedCap and will only be accessible by the study PI and the faculty sponsor. De-identified data of vital sign measurements will be shared between the Stanford research team and industry collaborators. Data will be downloaded to an encrypted USB key and hand-delivered between members of the research team. For smaller files, de-identified patient data will be mailed securely between the research team members.
Publications
W. Li, B. Tan and R. J. Piechocki,
Levitas, I. Naidionova and J. Matuzas,
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients
- ClinicalTrials.gov ID
- NCT04003415
- Acronym / sponsor ID
- IRB-51805
- Conditions
- Copd, Asthma, Respiratory Effort, Contactless Vital Sign Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Work of Breathing Study Group
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 1 Jul 2019 (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.
This study will test the accuracy of an investigational, non-invasive device for measuring heart rate and respiratory rate. The device emits radiowaves that allows it to pick up subtle changes in a person's chest wall, which allows it to calculate the heart rate and respiratory rate. We propose to study whether the device's measurements are accurate and reproducible in patients with chronic obstructive pulmonary disease (COPD) or asthma. The device undergoing study has been evaluated in healthy volunteers, but its accuracy in vital sign monitoring in patients with respiratory conditions has not yet been established. This study will serve as the foundation for additional work to assess the device's accuracy in measuring a patient's overall "work of breathing" or respiratory effort. Future work will examine the device's accuracy in measuring work of breathing in patients having an exacerbation of their underlying respiratory condition.
The primary aim of this study will be to assess the validity of heart rate and respiratory rate measurements in patients with either COPD or asthma.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants enrolled in the study will be in the intervention arm. Intervention consists of device feasibility and validation of heart rate and respiratory rate data collected.
| Arm | Type | Receives |
|---|---|---|
| Investigational Device Arm | Experimental | Device: Investigational Device: Contactless heart rate and respiratory rate monitor, Diagnostic Test: Heart Rate (EKG) Monitor, Diagnostic Test: Respiratory rate Monitor, Diagnostic Test: Pulse OximetryOnce consented for the study, participants will undergo testing with the investigational device for a one hour period. Testing will entail the participant wearing an EKG monitor, a respiratory rate monitor, a pulse oximeter, and being positioned next to the investigational device. The investigational device is contactless and captures chest movement of participants which allows it to estimate real time heart rate and respiratory rate. Additional data collected with the EKG monitor, respiratory rate monitor, and the pulse oximeter will be used to validate the vital sign data collected by the investigational device. After data collection is complete, participant involvement will then be over. Participants will have the option to return on a later date for additional testing (up to a maximum of three sessions total), within the six month window of the study. Participants will continue their standard of care therapies for their respiratory condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient seen at the Stanford University Hospital Chest Clinic
- Patient age 18 or older
- Patient able to consent
- Patient with one of the following two medical conditions: Chronic Obstructive Pulmonary - Disease or Asthma
- Participant (or accompanying family / caretaker) able to speak English
Key exclusion criteria (22 listed)
- Patient does not meet inclusion criteria (under age 18, unable to consent, etc.)
- Patient is hospitalized
- Patient is having an acute exacerbation of their respiratory condition
- Patient is having an acute exacerbation of a comorbid condition
- Patient has comorbid cardiac disease, including one of the conditions listed below:
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 |
|---|---|---|
| Investigational Device: Contactless heart rate and respiratory rate monitorAlso: Investigational DeviceParticipant will be seated next to the investigational device. The device is contactless, and will measure the patient's heart rate and respiratory rate through use of radio-waves. | Device | Investigational Device Arm |
| Heart Rate (EKG) MonitorParticipant will undergo 3-lead EKG testing to measure heart rate during testing. | Diagnostic test | Investigational Device Arm |
| Respiratory rate MonitorParticipant will have an elastic band around their chest for monitoring respiratory rate during testing. | Diagnostic test | Investigational Device Arm |
| Pulse OximetryParticipants will wear a finger pulse oximeter during the testing for monitoring of heart rate, respiratory rate, and pulse oximetry. | Diagnostic test | Investigational Device Arm |
Primary outcome
Heart Rate
Time frame: 30 - 60 minutes
Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.
Respiratory rate
Time frame: 30 - 60 minutes
Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.
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 28 Sep 2021.
- BackgroundW. Li, B. Tan and R. J. Piechocki,
- BackgroundLevitas, I. Naidionova and J. Matuzas,
- Reference 1Link provided by the sponsor.
- Reference 2Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Full Access: Access to Data, Access to patient PHI, Access to RedCap Document linking patients to their study numbers. Limited Access: Access to de-identified participant data for analysis Study PI and Study Faculty Sponsor: Full Access Research Team and Industry Sponsors: Limited Access Upon enrollment each participant will be assigned a unique study number. Any study data collected will be linked to the patient solely through the study number. The document that contains the patient information and their study numbers will by kept on Stanford RedCap and will only be accessible by the study PI and the faculty sponsor. De-identified data of vital sign measurements will be shared between the Stanford research team and industry collaborators. Data will be downloaded to an encrypted USB key and hand-delivered between members of the research team. For smaller files, de-identified patient data will be mailed securely between the research team members.
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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.
Andrea Jonas principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Device: Contactless heart rate and respiratory rate monitor, Heart Rate (EKG) Monitor and Respiratory rate Monitor in people with Copd and Asthma, run by Stanford University 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 5 inclusion and 22 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 28 Sep 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 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?
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?
Heart Rate (time frame: 30 - 60 minutes). 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?
On the ClinicalTrials.gov record for NCT04003415, which also lists 2 linked publications.
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 28 Sep 2021.