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Completed

NCT Number: NCT03819023

Validation of RespiLife for Detection of Respiratory Suppression

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.

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Key information

Conditions

Respiration Disorders Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peninsula Sleep Center

Burlingame, California, 94010-3224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respilife monitor

Diagnostic Test

Respilife monitor

Primary outcomes

  1. oxygen saturation percentage using photoplethysmography

    Time frame: 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.

  2. Respiratory rate, breaths per minute using photoplethysmography

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bioresp Technologies, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2019
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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