Funding, Publication Rate and Characteristics of Paediatric Sleep Apnea Clinical Trials: A Cross-Sectional Analysis.

OBJECTIVE

The objective of this study is to characterise available clinical trial information for paediatric obstructive sleep apnea (OSA) and identify opportunities for future research to better treat children with this condition.

METHODS

A cross-sectional analysis of paediatric OSA clinical trials was conducted using the International Clinical Trials Registry. Criteria for inclusion included sleep apnea trials with participants < 18 years old and an interventional design. We assessed the information available on the database to identify recent trends in research. We used PubMed to examine publication rate. NIH RePORTER was used to characterise funding patterns for trials conducted in the United States.

RESULTS

Of 91 trials analysed, 54% of trials were conducted in the United States. The number of paediatric OSA clinical trials has been increasing since 2005. Patients aged 6, 7 and/or 8 were enrolled in 70% of trials, whereas infants under 12 months of age were only represented in approximately 9%. Overall, 31.9% had results reported directly on the registry, while 57% had results published. Median time to trial completion by sponsor for US trials was 3.04 years for NIH-sponsored trials, 1.29 years for industry-sponsored trials, and 1.96 years for non-funded sources. The NIH funded 56% of US trials.

CONCLUSION

Despite a growing interest in paediatric OSA, continued focus on reporting and publishing results in a timely manner is essential to further advance the care of children with OSA. Future research should aim to address the gaps in age representation and focus on early intervention to treat age groups with higher prevalence.