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NCT03819023 Clinical Trial

Validation of RespiLife for Detection of Respiratory Suppression

Respiration Disorders Clinical Trial

Official title:
Validation of RespiLife for Detection of Respiratory Suppression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03819023
Other study ID # BR01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2018
Est. completion date March 20, 2019

Study information
Verified date April 2019
Source Bioresp Technologies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.

Description:

The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 20, 2019
Est. primary completion date March 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Able to understand and sign the informed consent

- English speaking.

- Able to comply with visits and follow ups included in this protocol

- Ages 18-80 years

Exclusion Criteria:

- Mentally or cognitively incompetent persons who cannot understand the procedures or consent to the procedures.

- An unstable medical condition, acute of chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.

- If a subject is not able to stop his CPAP or BiPAP therapy at least one week prior to the sleep study night. This will be determined ty the principal investigator based on her judgment.

- Skin rash on the forehead.

- A history of skin allergy to medical tape, even hypoallergenic tape.

- A history of skin cancer on the forehead.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Respilife monitor
Respilife monitor

Locations
Country Name City State
United States Peninsula Sleep Center Burlingame California

Sponsors (1)
Lead Sponsor Collaborator
Bioresp Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary oxygen saturation percentage using photoplethysmography The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer. 6 hours
Primary Respiratory rate, breaths per minute using photoplethysmography The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer and piezo electric and respiratory inductance plethysmography. 6 hours
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