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Validation of RespiLife for Detection of Respiratory Suppression

Primary Purpose

Respiration Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respilife monitor
Sponsored by
Bioresp Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiration Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Peninsula Sleep Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Normal subjects

respiratory suppressing drugs

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2019
Last Updated
April 3, 2019
Sponsor
Bioresp Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03819023
Brief Title
Validation of RespiLife for Detection of Respiratory Suppression
Official Title
Validation of RespiLife for Detection of Respiratory Suppression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
March 2, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioresp Technologies, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Evaluation of the device on people with normal and suppressed respiration
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal subjects
Arm Type
No Intervention
Arm Title
respiratory suppressing drugs
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Respilife monitor
Intervention Description
Respilife monitor
Primary Outcome Measure Information:
Title
oxygen saturation percentage using photoplethysmography
Description
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.
Time Frame
6 hours
Title
Respiratory rate, breaths per minute using photoplethysmography
Description
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.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Peninsula Sleep Center
City
Burlingame
State/Province
California
ZIP/Postal Code
94010-3224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Validation of RespiLife for Detection of Respiratory Suppression

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