NCT07217327RecruitingAccepts Healthy Volunteers
The DistaSense VITALS Study
Life Detection Technologies
Start Date
8/13/2025
Completion Date
11/1/2025
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
Age Range: 22 years to No maximum
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
Interventions
DIAGNOSTIC_TEST
DistaSense and Polysomnography
Conditions
Detection of Heart Rate and Respiratory Rate
Locations
Clayton Sleep Institute
St Louis, Missouri 63123
United States
CTI Clinical Research Center
Cincinnati, Ohio 45212
United States