Study on Mirtazapine's Role in Improving Sleep-Disordered Breathing: FHIR Data Structure Analysis

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This article details research data (ResearchStudy) identified as NCT04799782, titled 'Role of Mirtazapine in Ameliorating Sleep Disordered Breathing.' This data has been transformed into the FHIR format, demonstrating a standardized approach for handling academic research within medical information systems. The study employed a randomized placebo-controlled crossover design, involving blinded participants. Its purpose was to examine how Mirtazapine (15mg/day) affects sleep-disordered breathing. The subjects included adults (minimum age 18), with conditions such as Spinal Cord Injuries and Sleep Disordered Breathing, and also healthy volunteers. Technically, the research data is mapped onto the FHIR ResearchStudy resource structure. This allows for standardized handling of complex clinical trial progress statuses—such as 'Registration submission,' 'Results posting,' and 'Primary outcome data collection'—and detailed metadata. The ability to access this information via API is crucial. The publication of this dataset represents a significant case study in achieving interoperability by sharing international medical research outcomes using the common language of FHIR. Structuring the entire clinical trial lifecycle (from registration through results posting) and making it accessible via an API serves as an important data utilization model for the healthcare IT field.