Recruiting

DistaSense Sensor

Sponsor:

Life Detection Technologies

Code:

NCT07217327

Conditions

Detection of Heart Rate and Respiratory Rate

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

DistaSense and Polysomnography

Study Details

Brief 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

Detection of Heart Rate and Respiratory Rate

Study ID

NCT07217327

Start date

Aug 13, 2025

Status verified date

Sep, 2025

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

DistaSense and Polysomnography

All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.

Primary outcome measure

  • Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements [ Time Frame: Day 1 ]

Central Contacts and Locations

Locations

Clayton Sleep Institute

Recruiting

St Louis, Missouri, United States, 63123

Contacts

Chief Operating Officer; Co-Director CSI Research Center

314-645-5855UhlesM@claytonsleep.com

CTI Clinical Research Center

Recruiting

Cincinnati, Ohio, United States, 45212

Contacts

Senior Director of Research Site Operations

513-721-3868aroth@ctifacts.com

More Information

Sponsor

Life Detection Technologies

Last update posted

Nov 3, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Life Detection Technologies on 2025-11-03.