Validation of RespiLife for Detection of Respiratory Suppression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation of RespiLife for Detection of Respiratory Suppression

Conditions
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Respiration Disorders

Intervention / Treatment
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* Diagnostic Test: Respilife monitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Evaluation of the device on people with normal and suppressed respiration
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normal subjects<br> | |
| Active Comparator: respiratory suppressing drugs<br> | Diagnostic Test: Respilife monitor<br>* Respilife monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |