The DistaSense VITALS Study | NCT07217327

Studies
The DistaSense VITALS Study

NCT07217327

Sponsor

Life Detection Technologies

Status

Recruiting

Last Update Posted

Nov 3, 2025Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Detection of Heart Rate and Respiratory Rate

Interventions

DistaSense and Polysomnography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 13, 2025Actual

Primary Completion Date

Nov 2025Estimated

Completion Date

Nov 2025Estimated

First Submitted Date

Jul 30, 2025

First Submission Date that Met QC Criteria

Oct 13, 2025

First Posted Date

Oct 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2025

Last Update Posted Date

Nov 3, 2025Actual

Name	Class
Nilo Medical Consulting Group	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DistaSense and Polysomnography	Diagnostic Test	All subjects will be evaluated by DistaSense and reference device for respiratory rate and heart rate.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements		Day 1

Secondary Outcomes

Measure	Description	Time Frame
Mean absolute relative difference for each of HR and RR between the DistaSense and the reference		Day 1
Deming regression for each of the HR and RR data		Day 1

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Volunteers will be recruited via research subject databases from each site.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clayton Sleep Institute	Recruiting	St Louis	Missouri	63123	United States

Intervention Browse Module

MeSH Terms

ID	Term
D017286	Polysomnography

Ancestor Terms

ID	Term
D008991	Monitoring, Physiologic
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided