The DistaSense VITALS Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DistaSense and Polysomnography.
- Who it may be relevant to
- Registry conditions: Detection of Heart Rate and Respiratory Rate. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DistaSense: Two-Center Prospective, Non-Significant Risk (NSR) Study to Evaluate Heart Rate and Respiratory Rate Performance for Life Detection Technologies
Overview
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.
Interventions
- Diagnostic test DistaSense and Polysomnography
All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.
Primary outcome measures
- Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements [Time frame: Day 1]
Secondary outcome measures (2)
- Mean absolute relative difference for each of HR and RR between the DistaSense and the reference [Time frame: Day 1]
- Deming regression for each of the HR and RR data [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Age ≥ 22 years
- Fluent in English
- Willing and cognitively able to provide informed consent
- BMI < 36
- Expected by the investigator to achieve sufficient sleep duration for a minimum of 4 hours of meaningful data (e.g., absence of significant insomnia)
- Able to complete the scripted portion of the evaluation
Exclusion criteria
- Pregnant
- Sufficiently broken, damaged or irritated skin or rashes near the sensor application sites such that investigator believes should be precluded from enrollment
- Subjects with electronic implants of any kind (e.g. pacemaker)
- Subjects that are Life Detection Technology employees or shareholders, or family of a Life Detection Technology employee or shareholder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Clayton Sleep Institute — St Louis
- CTI Clinical Research Center — Cincinnati
Identifiers
NCT: NCT07217327 · TP-25-002