Detection of Heart Rate and Respiratory RateVITALSNCT07217327
The DistaSense VITALS Study
An observational study of Detection of Heart Rate and Respiratory Rate, run by Life Detection Technologies at 2 sites in United States.
Trial summary
A prospective, non-significant risk study designed to validate the performance of the DistaSense Contactless Sensor and algorithm for detecting heart rate and respiratory rate, compared to gold standard reference technology. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Detection of Heart Rate and Respiratory Rate
- What is being tested?
- DistaSense and Polysomnography
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers will be recruited via research subject databases from each site.
Who may be able to join
- Age ≥ 22 years
- Fluent in English
- Willing and cognitively able to provide informed consent
- BMI < 36
- Expected by the investigator to achieve sufficient sleep duration for a minimum of 4 hours of meaningful data (e.g., absence of significant insomnia)
- Able to complete the scripted portion of the evaluation
Who cannot join
- Pregnant
- Sufficiently broken, damaged or irritated skin or rashes near the sensor application sites such that investigator believes should be precluded from enrollment
- Subjects with electronic implants of any kind (e.g. pacemaker)
- Subjects that are Life Detection Technology employees or shareholders, or family of a Life Detection Technology employee or shareholder
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Senior Director of Research Site Operations, 513-721-3868, aroth@ctifacts.com
- Recruiting
Clayton Sleep Institute
St Louis, Missouri, 63123
Chief Operating Officer; Co-Director CSI Research Center, 314-645-5855, UhlesM@claytonsleep.com
About this study
Official title: DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies
A prospective, non-significant risk study designed to validate the performance of the DistaSense Contactless Sensor and algorithm for detecting heart rate and respiratory rate, compared to gold standard reference technology.
- Being tested
- DistaSense and Polysomnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DistaSense and PolysomnographyDiagnostic test
All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements
Measured: Day 1
Secondary outcomes (2)
Mean absolute relative difference for each of HR and RR between the DistaSense and the reference
Measured: Day 1
Deming regression for each of the HR and RR data
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start13 Aug 2025
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detection of Heart Rate and Respiratory RateStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Life Detection Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nilo Medical Consulting Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217327
- Sponsor's protocol ID
- TP-25-002
- Acronym
- VITALS
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2025
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies
- ClinicalTrials.gov ID
- NCT07217327
- Acronym / sponsor ID
- VITALS / TP-25-002
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Life Detection TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Nilo Medical Consulting Group
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 15 Oct 2025 (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.
A prospective, non-significant risk study designed to validate the performance of the DistaSense Contactless Sensor and algorithm for detecting heart rate and respiratory rate, compared to gold standard reference technology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers will be recruited via research subject databases from each site.
Key inclusion criteria (6 listed)
- Age ≥ 22 years
- Fluent in English
- Willing and cognitively able to provide informed consent
- BMI < 36
- Expected by the investigator to achieve sufficient sleep duration for a minimum of 4 hours of meaningful data (e.g., absence of significant insomnia)
Key exclusion criteria (4 listed)
- Pregnant
- Sufficiently broken, damaged or irritated skin or rashes near the sensor application sites such that investigator believes should be precluded from enrollment
- Subjects with electronic implants of any kind (e.g. pacemaker)
- Subjects that are Life Detection Technology employees or shareholders, or family of a Life Detection Technology employee or shareholder
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 |
|---|---|---|
| DistaSense and PolysomnographyAll subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate. | Diagnostic test | – |
Primary outcome
Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements
Time frame: Day 1
2 secondary outcomes
Mean absolute relative difference for each of HR and RR between the DistaSense and the reference
Time frame: Day 1
Deming regression for each of the HR and RR data
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Detection of Heart Rate and Respiratory Rate, run by Life Detection Technologies at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements (time frame: Day 1). 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 3 Nov 2025.