Bora Band Respiration Rate Study

NCT04064645 | Completed FDA Device

• 1 other identifier: PR2019-319
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Rate

Outcome Measures

Primary Outcomes (1)

• Accuracy of BORA Band respiratory rate measurements versus reference end-tidal CO2

  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

  5 days

Study Arms (1)

Respiratory rate accuracy measurement

EXPERIMENTAL

Device: Measurement of respiratory rate with DUT and comparison with reference

Interventions

Measurement of respiratory rate with DUT and comparison with reference DEVICE

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.

Respiratory rate accuracy measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosency: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark Laboratory

Louisville, Colorado, 80027, United States

Location

Study Officials

• Arthur Cabrera, MD

  Clinimark, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 22, 2019
• Study Start: June 25, 2019
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)