Clinical trial NCT04064645: Bora Band Respiration Rate Study
Official title: BiOSENCY Bora Band Respiration Rate Development and Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Rate
Lead sponsor: Biosency
Sponsor class: INDUSTRY
Collaborators: name: Clinimark, LLC
First posted: 2019-08-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the BORA BAND™ Wristband Monitoring System to the Reference. Respiratory Rate will be compared to an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda). The testing will be conducted in two phases. The first phase will be an initial data collection to assist in the algorithm development of respiration rate. Upon a successful Phase one performance, the second phase will be the Respiratory Rate Validation conducted at a different period in time.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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,
  * flu,
  * 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
  * cardiomyopathy
* Self-reported health conditions as identified in the Health Assessment Form

  * diabetes,
  * uncontrolled thyroid disease,
  * kidney disease / chronic renal impairment,
  * history of seizures (except childhood febrile seizures),
  * epilepsy,
  * 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

Primary outcomes:
measure: Accuracy of BORA Band respiratory rate measurements versus reference end-tidal CO2
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark Laboratory
state: Colorado
Study officials:
affiliation: Clinimark, LLC
name: Arthur Cabrera, MD
role: PRINCIPAL_INVESTIGATOR
References: