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Published on: December 6, 2016
Funding, Publication Rate and Characteristics of Paediatric Sleep Apnea Clinical Trials: A Cross-Sectional Analysis
Elizabeth M Puyo1, Jonathan M Carnino1, Frances Rodriguez Lara1
1Boston University Chobanian and Avedisian School of Medicine, Boston, Massachusetts, USA.
Insights
Clinical trials for paediatric obstructive sleep apnea (OSA) are increasing, but underrepresent infants. Future research should focus on early intervention and timely results reporting for better child OSA care.
Area of Science:
- Pediatric Sleep Medicine
- Clinical Trial Analysis
- Public Health Research
Background:
- Paediatric obstructive sleep apnea (OSA) is a growing concern requiring effective treatment strategies.
- Understanding the landscape of clinical research is crucial for advancing pediatric OSA care.
Purpose of the Study:
- To characterize available clinical trial information for pediatric obstructive sleep apnea (OSA).
- To identify research gaps and opportunities for improving the treatment of children with OSA.
Main Methods:
- Cross-sectional analysis of pediatric OSA clinical trials registered internationally.
- Inclusion criteria: interventional trials with participants under 18 years old.
- Data sources: International Clinical Trials Registry, PubMed, NIH RePORTER.
Main Results:
- 91 trials analyzed; 54% conducted in the US, with increasing numbers since 2005.
- Trials predominantly enrolled children aged 6-8 years (70%), with underrepresentation of infants (<12 months, ~9%).
- Results reporting varied: 31.9% on registry, 57% published; NIH funded 56% of US trials.
Conclusions:
- Despite increased research interest, timely reporting and publication of pediatric OSA trial results are essential.
- Future research should prioritize age representation, particularly for infants, and focus on early intervention strategies.
- Addressing these gaps will significantly advance the care and treatment outcomes for children with OSA.
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.
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