The DistaSense VITALS Study

Life Detection Technologies

Status: Enrolling

Conditions: Detection of Heart Rate and Respiratory Rate

Treatments: Diagnostic Test: DistaSense and Polysomnography

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07217327

TP-25-002

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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