DistaSense and Polysomnography: All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.
Study 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
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements — Day 1
Trial sites (2)
Facility
City
Region
Status
Clayton Sleep Institute
St Louis
Missouri
Recruiting
CTI Clinical Research Center
Cincinnati
Ohio
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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