Vital SignsVitalperceptNCT04935190
Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography
An observational study of Vital Signs, run by DawnLight at 1 site in United States.
Trial summary
1. Determine agreement (accuracy) of resting heart rate measured by Vitalpercept when compared to an FDA-cleared electrocardiograph (ECG) device, LifeSignals Wireless Biosensor. 2. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vital Signs
- What is being tested?
- Vitalpercept
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2021to 30 Oct 2021
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1. Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2.
Who may be able to join
- Male or female subjects ≥ 21 years of age at the time of signing the informed consent.
- Subjects willing to sign the informed consent and capable of committing to the duration of the study.
- Subjects with the ability to lie flat, lie on left side, lie on right side, and sit in a chair.
- Subjects who are able to breathe through their nose for the capnography assessment.
- Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1.
- Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2.
Who cannot join
- Subjects who are prone to excessive coughing and excessive movement
- Subjects who have a condition that involves uncontrollable movement of the body such as Parkinson's Disease or Essential Tremor.
- Subjects with a history of allergy to adhesive, latex or Nuprep.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Clinical Research
Raleigh, North Carolina, 27607
About this study
- Determine agreement (accuracy) of resting heart rate measured by Vitalpercept when compared to an FDA-cleared electrocardiograph (ECG) device, LifeSignals Wireless Biosensor.
- Determine agreement (accuracy) of resting respiratory rate measured by Vitalpercept when compared to an FDA-cleared capnographer, Capnostream 20.
- Conditions
- Vital Signs
- Being tested
- Vitalpercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalperceptDiagnostic test
Comparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1. Receives: Diagnostic Test: Vitalpercept | |
| Group 2 | Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2. Receives: Diagnostic Test: Vitalpercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events
Safety
Measured: During Data collection-Expected time=45-60 minutes
Measurement of Heart Rate
Effectiveness
Measured: During Data collection-Expected time=45-60 minutes
Measurement of Respiratory Rate
Effectiveness
Measured: During Data collection-Expected time=45-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start15 Jun 2021
- Primary completion30 Jul 2021
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DawnLight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935190
- Sponsor's protocol ID
- CP001
- Acronym
- Vitalpercept
- Status last verified
- Aug 2021
- First submitted
- 14 Jun 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography
- ClinicalTrials.gov ID
- NCT04935190
- Acronym / sponsor ID
- Vitalpercept / CP001
- Conditions
- Vital Signs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DawnLightIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 22 Jun 2021 (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.
- Determine agreement (accuracy) of resting heart rate measured by Vitalpercept when compared to an FDA-cleared electrocardiograph (ECG) device, LifeSignals Wireless Biosensor.
- Determine agreement (accuracy) of resting respiratory rate measured by Vitalpercept when compared to an FDA-cleared capnographer, Capnostream 20.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: VitalperceptSubjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1. |
| Group 2 | – | Diagnostic Test: VitalperceptSubjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1. Subjects who are not known to have a cardiac, pulmonary, or cardio-pulmonary condition will be assigned to Group 2.
Key inclusion criteria (6 listed)
- Male or female subjects ≥ 21 years of age at the time of signing the informed consent.
- Subjects willing to sign the informed consent and capable of committing to the duration of the study.
- Subjects with the ability to lie flat, lie on left side, lie on right side, and sit in a chair.
- Subjects who are able to breathe through their nose for the capnography assessment.
- Subjects that have a diagnosis of a cardiac, pulmonary, or cardio-pulmonary condition (e.g., Congestive Heart Failure, COPD, Asthma) will be assigned to Group 1.
Key exclusion criteria (3 listed)
- Subjects who are prone to excessive coughing and excessive movement
- Subjects who have a condition that involves uncontrollable movement of the body such as Parkinson's Disease or Essential Tremor.
- Subjects with a history of allergy to adhesive, latex or Nuprep.
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 |
|---|---|---|
| VitalperceptComparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography | Diagnostic test | Group 1, Group 2 |
Primary outcome
Incidence of Adverse events
Time frame: During Data collection-Expected time=45-60 minutes
Safety
Measurement of Heart Rate
Time frame: During Data collection-Expected time=45-60 minutes
Effectiveness
Measurement of Respiratory Rate
Time frame: During Data collection-Expected time=45-60 minutes
Effectiveness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of Vital Signs, run by DawnLight 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Aug 2021. 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?
Results are not available in the source record.
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?
Incidence of Adverse events (time frame: During Data collection-Expected time=45-60 minutes). The study lists 3 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 31 Aug 2021.