The DistaSense VITALS Study

Life Detection Technologies20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Detection of Heart Rate and Respiratory Rate

Interventions

DistaSense and PolysomnographyDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Clayton Sleep Institute

St Louis, Missouri, United States

RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Day 1

Secondary Outcomes

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

Time frame: Day 1

Deming regression for each of the HR and RR data

Time frame: Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.