NCT07217327

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

August 13, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2025

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

July 30, 2025

Last Update Submit

October 31, 2025

Conditions

Detection of Heart Rate and Respiratory Rate

Outcome Measures

Primary Outcomes (1)

  • Accuracy and bias between the DistaSense measurements of heart rate and respiratory rate and the reference measurements

    Day 1

Secondary Outcomes (2)

  • 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

Interventions

DistaSense and PolysomnographyDIAGNOSTIC_TEST

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

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

RECRUITING

MeSH Terms

Interventions

Polysomnography

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

October 15, 2025

Study Start

August 13, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

November 3, 2025

Record last verified: 2025-09

Locations

US(2)