NCT07147907

Respiratory Rate Validation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: Perin Health Devices · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-05-05
• Primary completion: 2025-05-22
• Completion: 2025-05-22
• First posted: 2025-08-29
• Last updated: 2025-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study