Peer-reviewed article
Participation of children with obstructive sleep apnea in clinical trials: a systematic review of barriers and interventions.
Wu L, Li X, Du Z, Wang X, Zhang X et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This systematic review examines barriers to clinical trial participation among children with obstructive sleep apnea (OSA), a sleep disorder that affects child development. The authors identified 28 studies describing obstacles across three domains: objective factors like eligibility criteria, provider factors, and patient/caregiver factors such as treatment disagreement. The review concludes that multiple barriers prevent adequate enrollment of children with OSA in research, limiting the evidence base for treatment.
Key points
- Fourteen barrier subcategories were identified across objective factors, provider factors, and patient/caregiver factors
- Most frequently reported barriers were stringent eligibility criteria, refusal of follow-up, treatment disagreement, and health problems
- Children with OSA remain underrepresented in clinical research despite the condition's negative effects on neurocognitive development and metabolic health
- Most current treatment evidence for OSA is based on adult data rather than pediatric-specific research
- Several underutilized solutions exist to facilitate participation, though formal targeted strategies are still needed
Limitations
This review identifies barriers and discusses interventions but does not evaluate the effectiveness of specific strategies to improve trial participation. It focuses specifically on OSA and may not generalize to other pediatric conditions or diseases.
Abstract
Background Obstructive sleep apnea (OSA) has negative effects on neurocognitive development and metabolic health in children. Despite this, children with OSA remain underrepresented in research; consequently, most evidence on treatment is based on adult data. This review focuses on studies assessing barriers to clinical trial participation in children with OSA and discusses intervention studies and efforts to overcome these barriers. Methods We retrieved articles from Scopus, Embase, PubMed, and the Cochrane Library without date restrictions until February 2026. The language used was restricted to English. The Joanna Briggs Institute (JBI) tool was used to assess methodological quality. Results Of the 28 included studies, 14 barrier subcategories were identified across three domains: objective factors (25 studies), provider factors (6 studies), and patient/caregiver factors (25 studies). The most frequently reported barriers were stringent eligibility criteria, refusal of follow-up, treatment disagreement, and health problem. Conclusions Our findings emphasize multifaceted barriers to enrolling children with OSA in clinical trials. Furthermore, we provided 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.