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NCT Number: NCT07217327

The DistaSense VITALS Study

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.

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Key information

Conditions

Detection of Heart Rate and Respiratory Rate

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clayton Sleep Institute, St Louis, Missouri, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

DistaSense and Polysomnography

Diagnostic Test

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

Primary outcomes

  1. Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements

    Time frame: Day 1

Secondary outcomes

  1. Mean absolute relative difference for each of HR and RR between the DistaSense and the reference

    Time frame: Day 1

  2. Deming regression for each of the HR and RR data

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Life Detection Technologies

Industry

Collaborators

  • Nilo Medical Consulting Group

Registry information

Official study title

DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies

Acronym: VITALS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2025
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.