Respiratory Rate Validation Study

Perin Health Devices

Status: Completed

Conditions: Respiration Rate; Monitoring, Physiologic

Treatments: Device: Chest Worn Respiratory Rate Monitor

Study type: Observational

Funder types: Industry

Identifiers

NCT07147907

PR 2025-644

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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.