Validation of RespiLife for Detection of Respiratory Suppression

Not Applicable

Completed

• Conditions: Respiration Disorders
• Interventions: Diagnostic Test: Respilife monitor

• Registration Number: NCT03819023
• Lead Sponsor: Bioresp Technologies, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Primary Completion: 2019-03-02
• Study Completion: 2019-03-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
respiratory suppressing drugs	Respilife monitor	-

Primary Outcome Measures

Name	Time	Method
oxygen saturation percentage using photoplethysmography	6 hours	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.
Respiratory rate, breaths per minute using photoplethysmography	6 hours	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.

Trial Locations

Locations (1)

Peninsula Sleep Center; 🇺🇸 Burlingame, California, United States