Status:

COMPLETED

Respiratory Rate Validation Study

Lead Sponsor:

Perin Health Devices

Conditions:

Respiration Rate

Monitoring, Physiologic

Eligibility:

All Genders

22+ years

Brief Summary

The goal of this clinical trial is to test how accurately a new chest-worn device called the Perin Health Patch measures breathing rate in adults aged 22 and older. The main question it aims to answer...

Eligibility Criteria

Inclusion

  • Participant must have the ability to understand and provide written informed consent.
  • Participants or legally authorized representative must be able to read or write in English.
  • Participant is adult, ages 22 years or older.
  • Participant must be willing and able to comply with study procedures and duration.

Exclusion

  • Participant unwilling or unable to provide written informed consent.
  • Participants evaluated by the Investigator and/or Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in Health Assessment Form and Health Screening.
  • Compromised circulation, injury, or physical malformation of the fingers, toes, hands, ears or forehead/skull or other sensor ROI, which would limit the ability to test ROI.
  • Tattoos in the optical path, which would limit the ability to test ROI. Certain malformations may still allow participants to participate if the condition is noted and would not affect the ROI.
  • Participants with severe contact allergies to standard adhesives, latex, or other materials found in pulse oximeters, ECG electrodes, or other medical sensors (self-reported).
  • Any other known health conditions may be evaluated and should be considered upon disclosure in health assessment form.

Key Trial Info

Start Date :

May 5 2025

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 22 2025

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT07147907

Start Date

May 5 2025

End Date

May 22 2025

Last Update

August 29 2025

Active Locations (1)

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1

Element Boulder

Louisville, Colorado, United States, 80027