RecruitingNCT07217327

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


Sponsor

Life Detection Technologies

Enrollment

20 participants

Start Date

Aug 13, 2025

Study Type

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

Min Age: 22 Years

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

DIAGNOSTIC_TESTDistaSense and Polysomnography

All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.


Locations(2)

Clayton Sleep Institute

St Louis, Missouri, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07217327