Validation of RespiLife for Detection of Respiratory Suppression

NCT ID: NCT03819023

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2019-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiration Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Evaluation of the device on people with normal and suppressed respiration
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal subjects

Group Type NO_INTERVENTION

No interventions assigned to this group

respiratory suppressing drugs

Group Type ACTIVE_COMPARATOR

Respilife monitor

Intervention Type DIAGNOSTIC_TEST

Respilife monitor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Respilife monitor

Respilife monitor

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bioresp Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peninsula Sleep Center

Burlingame, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BR01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.