Respiratory Rate Validation Study

NCT ID: NCT07147907

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2025-05-22

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 is:

How accurately does the Perin Health Patch measure breathing rate compared to a standard medical device that measures carbon dioxide in exhaled breath?

Participants will:

• Wear the Perin Health Patch on their chest during the study session
• Breathe through a mouthpiece or nose tube connected to a standard breathing monitor
• Follow guided breathing exercises at different speeds (from very slow to fast breathing) using a breathing app
• Sit and lie down in different positions during the measurements
• Complete the study in one visit lasting about 1-2 hours

The study will include both healthy adults and people with conditions like asthma, COPD, heart failure, diabetes, high blood pressure, or obesity to test how well the device works for different types of people. Researchers will compare the breathing rate numbers from the new chest patch to the standard medical device to see if the patch is accurate enough for medical use.

Conditions

Respiration Rate; Monitoring, Physiologic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Chest Worn Respiratory Rate Monitor

The Perin Health Patch is a non-invasive, chest-worn wearable device designed to continuously monitor physiological signals, including respiratory rate and other health metrics. In this study, the device will be evaluated for its ability to accurately measure respiratory rate during controlled breathing exercises in healthy adult volunteers. The respiratory rate values recorded by the Perin Health Patch will be compared against respiratory rate measurements obtained via manually scored end tidal carbon dioxide (EtCO2) waveforms from a GE Datex-Ohmeda monitor, following Element Laboratory protocols aligned with clinical validation standards. The intervention in this study is limited to the application and use of the device for data collection during controlled respiratory rate conditions, where participants perform paced breathing exercises at various rates (5-50 breaths per minute) using a breathing app while positioned sitting or lying supine.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Perin Health Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Element Boulder

Louisville, Colorado, United States

Countries

United States

Other Identifiers

PR 2025-644

Identifier Type: -

Identifier Source: org_study_id