Virtual Home Spirometry

Home-based spirometry enables patients to perform pulmonary function testing outside of traditional clinical settings, offering several significant advantages for both research and clinical care.

• More frequent measurements:
  Frequent measurements at home enables capturing day-to-day variability in respiratory function, which can be missed during periodic site visits. Increased measurement frequency contributes to a richer and more granular dataset, providing a more comprehensive understanding of disease progression and therapeutic response over time.
• Reduced logistical and physical burden on participants:
  By minimizing the need for travel to clinical sites, thereby improving patient convenience and adherence.

When implemented with appropriate training, standardized protocols, and remote monitoring technologies, home-based spirometry can deliver high-quality, reliable data that meets regulatory standards while supporting patient-centric trial designs.

Data quality in home-based pulmonary function testing is safeguarded by using regulatory-cleared portable devices, properly training participants, and implementing virtual coaching during spirometry maneuvers.

Once collected, data are transmitted securely via encrypted channels to centralized servers, where a core laboratory performs systematic review and quality assurance. This centralized oversight includes monitoring reproducibility, plausibility, and compliance with established guidelines.

To further enhance reliability, Clario integrates advanced artificial intelligence (AI) algorithms that support adherence to American Thoracic Society (ATS) and European Respiratory Society (ERS) standards to identify the quality of spirometry maneuvers.

These combined measures (validated technology, patient training, secure data handling, centralized review, and AI-driven quality control) create a robust framework for ensuring accuracy and regulatory acceptability in decentralized respiratory data collection.

Home-based spirometry introduces several critical challenges that must be addressed to ensure data integrity and regulatory compliance. Foremost among these is maintaining patient adherence to prescribed testing schedules, as inconsistent or missed measurements can compromise longitudinal data quality and study endpoints.

Additionally, the absence of trained technicians during home testing increases the risk of procedural errors, such as improper device handling, inadequate effort during maneuvers, or failure to meet acceptability and repeatability criteria outlined in standardized guidelines.

Connectivity issues present another potential concern, as interruptions in data transmission can lead to incomplete datasets, delayed monitoring, and risk for loss of clinically relevant information.

Effective mitigation strategies include comprehensive patient training, real-time remote oversight, automated quality checks, and robust data synchronization protocols to safeguard accuracy and completeness.

Compliance in home-based respiratory testing is typically monitored through integrated device logs that record usage patterns, timestamps, and test completion status. These logs provide objective evidence of patient engagement and facilitate centralized oversight.

Advanced data management platforms often incorporate real-time dashboards that enable study sites and sponsors to track adherence, identify missed or delayed measurements, and intervene promptly when deviations occur.

To further support compliance, many clinical trials employ patient engagement strategies such as automated reminders, mobile applications, and digital health tools designed to reinforce testing schedules and improve user experience.

These approaches, combined with proactive communication and education, help maintain high adherence rates and ensure the integrity of longitudinal data collection.