- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07147907
Respiratory Monitoring Technology Validation Study for Patients
Perin Health Devices is conducting an important clinical research study to validate the accuracy of their innovative chest-worn respiratory rate monitor. This observational study will carefully evaluate how well this wearable medical device measures breathing rates compared to established hospital monitoring equipment. The research is specifically designed to ensure the technology works reliably for diverse adult populations across different health conditions.
The study will enroll between 35-80 participants aged 22 years and older, including both healthy volunteers and individuals with various health conditions such as COPD, asthma, heart failure, diabetes, hypertension, and obesity. This diverse participation ensures the device is tested across the full spectrum of breathing rates and different physical characteristics. The researchers are making special efforts to include participants with various skin tones, body mass indexes, ages, and racial backgrounds to guarantee the technology works effectively for everyone.
For patients and caregivers, this research represents an important step toward better home monitoring solutions for respiratory health. Many individuals with chronic breathing conditions struggle with frequent hospital visits and the anxiety of not knowing when their breathing might become problematic. A reliable wearable monitor could provide peace of mind by offering continuous, accurate breathing rate measurements in the comfort of one's home. This technology could help detect early warning signs of respiratory distress, potentially preventing emergencies and reducing hospital admissions.
The study involves a single in-lab session lasting approximately one hour per participant. During this session, researchers will compare the chest-worn monitor's measurements against gold-standard end tidal CO2 monitoring equipment while participants perform paced breathing exercises. The careful comparison methodology ensures that any future patients using this device can trust its accuracy. The research team will be assessing multiple statistical measures including mean absolute error, accuracy root mean square, bias, and standard deviation to thoroughly validate the technology's performance.
For individuals considering participation, the eligibility criteria are straightforward: participants must be adults who can understand and provide consent in English, be willing to comply with study procedures, and not have certain specific exclusions like severe adhesive allergies or tattoos in the measurement areas. The research team conducts health screenings to ensure participant safety throughout the study process.
Respiratory monitoring technology represents a significant advancement in patient care, particularly for those managing chronic conditions that affect breathing. Traditional monitoring often requires clinical settings and specialized equipment, but wearable technology enables continuous monitoring during daily activities. This shift toward patient-centered monitoring empowers individuals to take more active roles in managing their health while providing healthcare providers with valuable longitudinal data.
The importance of this research extends beyond the specific device being tested. As wearable health technology continues to evolve, rigorous validation studies ensure that these innovations meet medical standards for accuracy and reliability. Patients and caregivers should feel confident that devices reaching the market have undergone thorough testing across diverse populations. This study contributes to the broader field of remote patient monitoring, which is transforming how healthcare is delivered by enabling early intervention and reducing the burden on healthcare systems.
For those living with respiratory conditions, reliable home monitoring can significantly improve quality of life by reducing anxiety about sudden breathing difficulties and providing objective data to share with healthcare providers. It enables more personalized treatment adjustments and earlier detection of complications. This research represents hope for more independent living while maintaining connection to professional medical oversight through technology.
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