Cross-sectional analysis of safety reporting in sleep disorder clinical trials.

STUDY OBJECTIVES: Adverse event reporting is critical for evaluating the safety of interventions in sleep disorders. Inconsistent reporting between trial registries and publications may alter clinical decision-making and patient safety. We assessed the concordance of adverse event reporting between ClinicalTrials.gov and peer-reviewed publications for interventional trials in sleep disorders. Primary outcomes included the consistency of reporting serious adverse events, other adverse events and patient/event counts. The location and detail of adverse event reporting within publications were also evaluated. METHODS: RESULTS: Among 168 trials, 143 (85.1%) showed discrepancies in serious adverse event counts between registry and publication. Patient count variations occurred in 73.2% and 35.1% of publications reported no adverse event data. Post-Final Rule trials demonstrated improved registry-based reporting, though discordance remained. CONCLUSIONS: Substantial inconsistencies in adverse event reporting between registries and publications persist in sleep disorder trials. Improved standardisation and adherence to reporting guidelines are necessary to protect patient safety. TRIAL REGISTRATION DETAILS: Registered on Open Science Framework.