DistaSense VITALS: contactless heart- and breathing-rate validation.
Official title: DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies
Run by Life Detection Technologies · NCT07217327 · Data updated 2026-11-12
This study will test whether the DistaSense contactless sensor can accurately measure heart rate and breathing rate in adults while they sleep, compared with standard polysomnography.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Life Detection Technologies Industry-sponsored |
| Locations | 2 sites (St Louis, Missouri and 1 other locations) |
| Status | Recruiting |
| Started | August 13, 2025 |
| Main results expected | November 2025 |
| Study ends | November 2025 |
| Registry record updated | November 3, 2025 |
| Trial ID | NCT07217327 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 22 or older who can consent, speak English, have BMI under 36, can expect at least four hours of sleep during the visit, and have no electronic implants or disqualifying skin issues.
✕Probably not a fit
People who are pregnant, have implanted electronic devices, have broken or irritated skin near sensor sites, or cannot achieve sufficient sleep are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-significant-risk observational study that compares the DistaSense contactless sensor and its algorithm to gold-standard polysomnography for detecting heart rate and respiratory rate. Eligible adults (age ≥22, BMI <36, fluent in English) will undergo overnight data collection with both the DistaSense device and polysomnography, aiming for at least four hours of usable sleep data. Participants with electronic implants, pregnancy, or skin issues near sensor sites are excluded. The study is conducted at two U.S. sleep sites with device-versus-reference signal comparison and algorithm performance metrics as the primary outcomes.
Why it matters
Potential benefit: If successful, the device could provide accurate, non-contact monitoring of heart and breathing rates during sleep, making vital-sign tracking easier and less intrusive for patients.
How similar studies have gone: Prior research on contactless vital-sign monitoring has shown promising results, but device-specific validation like this is still needed to confirm performance.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Clayton Sleep Institute
St Louis, Missouri, United States Recruiting -
CTI Clinical Research Center
Cincinnati, Ohio, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.