Detection of Heart Rate and Respiratory Rate
Conditions
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.
Interventions
DIAGNOSTIC_TESTDistaSense and Polysomnography
All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.
Sponsors
Nilo Medical Consulting Group
Life Detection Technologies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Mean absolute relative difference for each of HR and RR between the DistaSense and the reference | Day 1 |
| Deming regression for each of the HR and RR data | Day 1 |
Countries
United States
Outcome results
None listed