Trials / Recruiting
RecruitingNCT07217327
The DistaSense VITALS Study
DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Life Detection Technologies · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | DistaSense and Polysomnography | All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate. |
Timeline
- Start date
- 2025-08-13
- Primary completion
- 2025-11-01
- Completion
- 2025-11-01
- First posted
- 2025-10-15
- Last updated
- 2025-11-03
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07217327. Inclusion in this directory is not an endorsement.