Respiration DisordersNCT03819023
Validation of RespiLife for Detection of Respiratory Suppression
A study testing Respilife monitor in people with Respiration Disorders, run by Bioresp Technologies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiration Disorders
- What is being tested?
- Respilife monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Peninsula Sleep Center
Burlingame, California, 94010-3224
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.
Read the 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.
- Conditions
- Respiration Disorders
- Being tested
- Respilife monitor
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respilife monitorDiagnostic test
Respilife monitor
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | No intervention | Not described |
| respiratory suppressing drugs | Active comparator | Not described Receives: Diagnostic Test: Respilife monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
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.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start20 Dec 2018
- Primary completion2 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation of the device on people with normal and suppressed respiration
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioresp Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819023
- Sponsor's protocol ID
- BR01
- Status last verified
- Apr 2019
- First submitted
- 15 Jan 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of RespiLife for Detection of Respiratory Suppression
- ClinicalTrials.gov ID
- NCT03819023
- Acronym / sponsor ID
- BR01
- Conditions
- Respiration Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bioresp Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluation of the device on people with normal and suppressed respiration
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | No intervention | – |
| respiratory suppressing drugs | Active comparator | Diagnostic Test: Respilife monitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respilife monitorRespilife monitor | Diagnostic test | respiratory suppressing drugs |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respilife monitor in people with Respiration Disorders, run by Bioresp Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen saturation percentage using photoplethysmography (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.