Status:

RECRUITING

The DistaSense VITALS Study

Lead Sponsor:

Life Detection Technologies

Collaborating Sponsors:

Nilo Medical Consulting Group

Conditions:

Detection of Heart Rate and Respiratory Rate

Eligibility:

All Genders

22+ years

Brief 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 standa...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 13 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2025

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT07217327

Start Date

August 13 2025

End Date

November 1 2025

Last Update

November 3 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Clayton Sleep Institute

St Louis, Missouri, United States, 63123

2

CTI Clinical Research Center

Cincinnati, Ohio, United States, 45212

The DistaSense VITALS Study | DecenTrialz