Validation of RespiLife for Detection of Respiratory Suppression

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03819023

Enrollment

Registered

2019-01-28

Start date

2018-12-20

Completion date

2019-03-20

Last updated

2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration Disorders

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

Interventions

DIAGNOSTIC_TESTRespilife monitor

Respilife monitor

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Evaluation of the device on people with normal and suppressed respiration

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026