The DistaSense VITALS Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorLife Detection Technologies
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 22 years
Fluent in English
Willing and cognitively able to provide informed consent
BMI < 36
Disqualifiers
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 population
Volunteers will be recruited via research subject databases from each site.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
DistaSense and Polysomnography
Diagnostic testAll subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements
Time frame
Day 1Secondary outcomes
1
Mean absolute relative difference for each of HR and RR between the DistaSense and the reference
Time frame
Day 12
Deming regression for each of the HR and RR data
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Life Detection Technologies
Lead sponsor
Nilo Medical Consulting Group
Collaborator
Source ClinicalTrials.gov