Status:
COMPLETED
Bora Band Respiration Rate Study
Lead Sponsor:
Biosency
Collaborating Sponsors:
Clinimark, LLC
Conditions:
Respiratory Rate
Eligibility:
All Genders
18+ years
Phase:
NA
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 cleare...
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 repre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2019
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04064645
Start Date
June 25 2019
End Date
July 25 2019
Last Update
August 22 2019
Active Locations (1)
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1
Clinimark Laboratory
Louisville, Colorado, United States, 80027