The DistaSense VITALS Study
DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies
Life Detection Technologies
20 participants
Aug 13, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria4
- 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
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Interventions
All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07217327