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Validation of RespiLife for Detection of Respiratory Suppression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819023
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Bioresp Technologies, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Respiration Disorders Diagnostic Test: Respilife monitor Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Evaluation of the device on people with normal and suppressed respiration
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of RespiLife for Detection of Respiratory Suppression
Actual Study Start Date : December 20, 2018
Actual Primary Completion Date : March 2, 2019
Actual Study Completion Date : March 20, 2019
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Normal subjects
Active Comparator: respiratory suppressing drugs Diagnostic Test: Respilife monitor
Respilife monitor


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819023


Locations
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United States, California
Peninsula Sleep Center
Burlingame, California, United States, 94010-3224
Sponsors and Collaborators
Bioresp Technologies, Inc.
More Information
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Responsible Party: Bioresp Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03819023    
Other Study ID Numbers: BR01
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases