An interventional study of Investigational Device: Contactless heart rate and respiratory rate monitor and Heart Rate (EKG) Monitor in Copd, Asthma and Respiratory Effort, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Stanford University · Not applicable, Interventional, and Device feasibility
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.
513 studies on the registry are indexed under Respiration Disorders; 98 are open to participants now.
This study's enrollment of 12 is below the median of 64 across 290 interventional studies indexed under Respiration Disorders.
Browse Respiration Disorders studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
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.
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
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.
Also known as: Investigational Device
Participant will undergo 3-lead EKG testing to measure heart rate during testing.
Participant will have an elastic band around their chest for monitoring respiratory rate during testing.
Participants will wear a finger pulse oximeter during the testing for monitoring of heart rate, respiratory rate, and pulse oximetry.
Heart Rate
Heart rate data as compared between the investigational device, a 3-lead EKG, and a finger probe.
Time frame: 30 - 60 minutes
Respiratory rate
Respiratory rate data as compared between the investigational device, a respiratory rate monitor, and a finger probe.
Time frame: 30 - 60 minutes
Plan to share: 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.
Supporting information: Study protocol, Sap
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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