The DistaSense VITALS Study

NCT ID: NCT07217327

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-13

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Detection of Heart Rate and Respiratory Rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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DistaSense and Polysomnography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nilo Medical Consulting Group

UNKNOWN

Sponsor Role collaborator

Life Detection Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clayton Sleep Institute

St Louis, Missouri, United States

Site Status RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Chief Operating Officer; Co-Director CSI Research Center

Role: primary

314-645-5855

Senior Director of Research Site Operations

Role: primary

513-721-3868

Other Identifiers

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TP-25-002

Identifier Type: -

Identifier Source: org_study_id

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