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Recruiting NCT07217327

The DistaSense VITALS Study

Trial Parameters

Condition Detection of Heart Rate and Respiratory Rate
Sponsor Life Detection Technologies
Study Type OBSERVATIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 22 Years
Max Age N/A
Start Date 2025-08-13
Completion 2025-11
Interventions
DistaSense and Polysomnography

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 standard reference technology.

Eligibility Criteria

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

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