Participation of children with obstructive sleep apnea in clinical trials: A systematic review of barriers and interventions
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Background Obstructive sleep apnea (OSA) in children is associated with negative effects on neurocognitive development and metabolic health. Despite this, children with OSA remain underrepresented in research, setting the standards for clinical diagnoses and treatments. Consequently, most evidence on treatment is based on adult data. This review focuses on studies assessing the barriers to clinical trial participation for children with OSA and discusses the intervention studies and efforts to overcome these barriers. Method We retrieved articles from Scopus, Embase, PubMed, and the Cochrane Library without date restrictions until May 2024. The language was restricted to English. The Joanna Briggs Institute (JBI) tool was used to assess methodological quality. Results From 25 studies included, 14 barrier subcategories were identified, which were classified as an objective factor, provider, and patient/caregiver. Conclusions Our findings emphasize the multifaceted barriers to enrolling children with OSA in clinical trials. Furthermore, we provide several underutilized solutions to facilitate children's participation in clinical trials. However, formal targeted strategies are still needed in the future because these recommendations alone might not solve the evidence gap in children. Registration: Registered in PROSPERO with ID: CRD42024533326.
