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100's of Published papers demonstrating expertise in sleep and respiratory device trials

BSC's published research in sleep medicine reflects deep domain knowledge in polysomnography endpoints and respiratory assessments. We translate this expertise into regulatory strategies that anticipate FDA expectations and accelerate your path to approval for ventilators, sleep apnea devices, and respiratory diagnostics.

Respiratory & Sleep Medicine

Overview

BSC provides statistical expertise for respiratory devices and sleep medicine technologies, including ventilators, respiratory monitoring systems, sleep apnea treatment devices, and pulmonary diagnostics. Our experience spans both acute respiratory conditions and chronic sleep disorders. Multiple team members have decades of experience at University of Pennsylvania Sleep Center as directors of the biostatistics core.

Specialized Capabilities

Apnea-hypopnea index (AHI) analysis and responder definitions. Sleep stage analysis and architecture assessments. Polysomnography endpoint design. Respiratory function testing (spirometry, gas exchange). Long-term adherence modeling for sleep therapy devices.

Regulatory Experience

We understand FDA expectations for sleep disorder treatment devices, including appropriate sham controls, objective outcome measurement, and long-term effectiveness assessment. Our team has experience with both home sleep testing and laboratory polysomnography endpoints.

Representative Studies

  • CPAP and BiPAP devices for sleep apnea
  • Oral appliances for sleep-disordered breathing
  • Home sleep testing devices
  • Respiratory monitoring and diagnostic systems
  • Pulmonary function testing equipment
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