DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies
Life Detection Technologies
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
- Age range
- 22+ years
- Sex
- All
- 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. pace…
Interventions
- Diagnostic TestDistaSense and Polysomnography
All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.
Locations (2)
- Clayton Sleep InstituteSt Louis, Missouri
- CTI Clinical Research CenterCincinnati, Ohio