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NCT07217327RecruitingAccepts Healthy Volunteers

The DistaSense VITALS Study

Life Detection Technologies

Start Date

8/13/2025

Completion Date

11/1/2025

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 Criteria

Age Range: 22 years to No maximum

Inclusion Criteria: 1. Age ≥ 22 years 2. Fluent in English 3. Willing and cognitively able to provide informed consent 4. BMI \< 36 5. Expected by the investigator to achieve sufficient sleep duration for a minimum of 4 hours of meaningful data (e.g., absence of significant insomnia) 6. Able to complete the scripted portion of the evaluation Exclusion Criteria: 1. Pregnant 2. Sufficiently broken, damaged or irritated skin or rashes near the sensor application sites such that investigator believes should be precluded from enrollment 3. Subjects with electronic implants of any kind (e.g. pacemaker) 4. Subjects that are Life Detection Technology employees or shareholders, or family of a Life Detection Technology employee or shareholder

Interventions

DIAGNOSTIC_TEST

DistaSense and Polysomnography

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Conditions

Detection of Heart Rate and Respiratory Rate

Locations

Clayton Sleep Institute

St Louis, Missouri 63123

United States

CTI Clinical Research Center

Cincinnati, Ohio 45212

United States