Bora Band Respiration Rate Study
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|ClinicalTrials.gov Identifier: NCT04064645|
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Respiratory Rate||Device: Measurement of respiratory rate with DUT and comparison with reference||Not Applicable|
For phase 1, there will be 5 to 6 volunteer test subjects. For the final validation phase, there will be a minimum of 20 volunteer test subjects. All subjects will be 18 or older and selected to represent a range of body types including small, average, muscular, and large with a range of BMI's.
Each subject will be connected to a commonly used, FDA cleared ECG Impedance monitor (to be used for informational purposes) and an End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and BiOSENCY BORA BAND™ wristband monitoring system. The end tidal CO2 monitor will be attached to the patient to determine performance of respiratory rate metrics (Reference). Each subject will be instrumented with a mouthpiece that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate (Reference) and tidal volume.
A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40, 45 and 50 breaths per minute; with some natural variation from these exact numbers. Paced breathing app will be used. Not all subjects will be able to breathe at a constant level for every rate.
The respiratory rate will be measured simultaneously with EtCO2 (Reference) and the Devices Under Test.
For the data analysis, the EtCO2 monitor will be used to assess the stability of the data. If the respiratory rate varies by more than +3 bpm during a one-minute period of the target respiration rates, then the data for that period will be considered unstable and removed from analysis.
To 'Pass' this test the BiOSENCY BORA BAND™ wristband (Device Under Test) must demonstrate a Respiratory Rate of ≤3 when compared to the Reference End tidal carbon dioxide monitor.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BiOSENCY Bora Band Respiration Rate Development and Validation Study|
|Actual Study Start Date :||June 25, 2019|
|Actual Primary Completion Date :||July 25, 2019|
|Actual Study Completion Date :||July 25, 2019|
|Experimental: Respiratory rate accuracy measurement||
Device: Measurement of respiratory rate with DUT and comparison with reference
The subject will follow the paced breathing app, once a stable Respiration Rate at the natural rate (without the breathing app) is captured. The breathing pattern on the app will be set to begin near the normal Respiration Rate of the subject and continue to go down by five intervals until reaching the Respiration Rate of 5 bpm. After that, we will pick back up at the rate above the subject's normal Respiration Rate and continue upwards until reaching 50 bpm or as high as the subject can tolerate up to 50 bpm.
The respiratory rate will be monitored simultaneously with an EtCo2 (Reference) and the BORA BAND™ wristband monitoring system, Device Under Test. These data will be continuously recorded electronically. Additional study notes that describe conditions of the test as well as deviations, device issues and any adverse events will be recorded in written documentation.
- Accuracy of BORA Band respiratory rate measurements versus reference end-tidal CO2 [ Time Frame: 5 days ]
Accuracy of the BORA Band respiratory rate measurement as compared to reference end-tidal CO2.
Results shall include:
- Respiratory rate root mean square accuracy of BORA Band
- Respiratory rate bias of BORA Band
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Subject must have the ability to understand and provide written informed consent
- Subject is adult over 18 years of age
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker
- Male or female of any race
- Wrist circumference with the range of 5.5-8 inches (13 to 21cm)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoo in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
Subjects with known respiratory conditions such as:
- uncontrolled / severe asthma,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- respiratory or lung surgery,
- emphysema, COPD, lung disease
Subjects with self-reported heart or cardiovascular conditions such as:
- have had cardiovascular surgery
- Chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
Self-reported health conditions as identified in the Health Assessment Form
- uncontrolled thyroid disease,
- kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent head injury within the last 2 months,
- Cancer / chemotherapy
- Other known health condition, should be considered upon disclosure in health assessment form
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): NCT04064645
|United States, Colorado|
|Louisville, Colorado, United States, 80027|
|Principal Investigator:||Arthur Cabrera, MD||Clinimark, LLC|
|Other Study ID Numbers:||
|First Posted:||August 22, 2019 Key Record Dates|
|Last Update Posted:||August 22, 2019|
|Last Verified:||August 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|