Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients
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|ClinicalTrials.gov Identifier: NCT04003415|
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Copd Asthma Respiratory Effort Contactless Vital Sign Monitoring||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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Respiratory Disorders Non-invasive Monitoring of Work of Breathing in Outpatients|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
Experimental: Investigational Device Arm
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
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.
Other Name: Investigational Device
Diagnostic Test: Heart Rate (EKG) Monitor
Participant will undergo 3-lead EKG testing to measure heart rate during testing.
Diagnostic Test: Respiratory rate Monitor
Participant will have an elastic band around their chest for monitoring respiratory rate during testing.
Diagnostic Test: Pulse Oximetry
Participants will wear a finger pulse oximeter during the testing for monitoring of heart rate, respiratory rate, and pulse oximetry.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003415
|Contact: Andrea Principal Investigator||650 725 firstname.lastname@example.org|
|United States, California|
|Stanford University||Not yet recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Andrea Jonas, MD 650-725-7061 email@example.com|
|Principal Investigator:||Andrea Jonas||Stanford University|