Participation of children with obstructive sleep apnea in clinical trials: a systematic review of barriers and interventions

Introduction

Obstructive sleep apnea (OSA) is a common sleep-breathing disorder. OSA is a major global health problem that can lead to adverse health outcomes (1). OSA in children is a condition that differs from that in adults regarding etiology, clinical presentation, and consequences (2). Studies have suggested OSA prevalence in children of 1–5% (3), with most affected children aged 2–8 years (4). Evidence shows that if untreated, pediatric OSA may lead to serious complications (5), such as dentofacial deformities (adenoid face), decreased attention, decreased academic performance, neurobehavioral problems, disturbed emotional regulation, impaired growth, endocrine disorders, pulmonary hypertension, and systemic hypertension (6,7).

However, children are vastly underrepresented in clinical trials setting standards for diagnosis and intervention, leading to a lack of uniform standards for OSA diagnosis and treatment guidelines in children (2). Even when children are enrolled in clinical trials, they typically receive less attention than the general population treated in clinical practice (i.e., adults). Consequently, most evidence about the benefits and risks of OSA therapeutics has been extrapolated from adults, subsequently leading to restricted disparities in clinical diagnosis and treatment strategies in children with OSA.

Although children’s participation in clinical trials has been the subject of frequent inquiries, this issue remains unresolved (8,9). Several studies have described the barriers as multifaceted, often involving a combination of caregiver, patient, and provider factors (10-12).

To extend the existing evidence base and address the limitations of prior reviews, we conducted this systematic review focusing on children with OSA as participants in clinical trials more broadly. This review aims to analyze the underlying reasons for barriers to the participation of children with OSA in clinical trials, as well as efforts to overcome these barriers. Evidence from such qualitative analysis would provide effective strategies on overcoming the barriers to clinical trial enrollment and facilitate the inclusion of children in OSA clinical trials. We present this article in accordance with the PRISMA reporting checklist (available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0399/rc).

Methods

This study was registered in PROSPERO with ID: CRD42024533326.

Search strategy

The Embase, Scopus, PubMed, and Cochrane Library searches identified relevant studies published up to February 2026. The search strategy was developed with relevant population, intervention, comparison, and outcome terms linked using the AND operator: (I) children (pediatrics, etc.); (II) OSA (sleep disorder breathing, apneic, etc.); (III) clinical trials (therapeutic research, human experimentation, etc.); (IV) participation (eligibility, patient selection, etc.). A manual search of reference lists of articles retrieved online was conducted to identify other studies that might have been missed. Table S1 shows the search strategy used.

Literature inclusion and exclusion criteria

Two authors (Z.D. and X.W.) independently screened the included studies for their eligibility. Disagreements were resolved through discussion or judged by a third reviewer (L.W.). Studies were included if they (I) were full-text articles of empirical, peer-reviewed experimental, quasi-experimental, or observational studies published in English and (II) focused on patients with OSA aged <18 years. Studies were excluded if they (I) had no available data to extract and (II) described the situation but did not state the reasons for the low enrollment of children with OSA. Two independent authors (L.W. and X.L.) extracted data indicating the year of publication, geographic location, author, study type, sample size, age, interventions, and study duration according to a standardized template of the Cochrane Collaboration and resolved disagreements through discussion.

Quality and risk assessment

In this study, the Joanna Briggs Institute (JBI) (13), a set of tailored quality assessment tools specific to certain study designs and tested for potential flaws in the study methods or implementation, was used to evaluate the quality of the included studies.

Results

Identification of relevant studies

A total of 12,561 studies were identified, and 1,528 duplicates were removed. Furthermore, 10,781 records were removed during the evaluation of titles and abstracts because they were irrelevant to the review question. The full texts of 252 reports were retrieved and evaluated, and 28 were qualified for the systematic review (Figure 1). Since quantitative synthesis (meta-analysis) was not possible due to the diverse nature of data across studies, qualitative synthesis was performed.

Figure 1 Flow diagram of the literature search and study selection process.

Characteristics of included studies

Table 1 summarizes the characteristics of each study. Of the included studies, 9 were observational studies [4 cross-sectional (18,23,30,31) and 5 cohort studies (15,24,29,32,39)] and 19 were controlled intervention studies [2 quasi-experimental studies (22,34) and 17 randomized controlled trials (RCTs) (14,16,17,19-21,25-28,33,35-38,40,41)]. Most studies were conducted in the USA (n=12) (15,16,22,25,26,31,33,35-38,41) and Australia (n=5) (17,27,29,32,34), followed by Vietnam (n=1) (18), Brazil (n=1) (19), Israel (n=1) (21), Canada (n=4) (23,24,30,40), Sweden (n=2) (14,28), Finland (n=1) (39), and China (n=1) (20). The studies were published between 1996 and 2025. The main influencing factors were parent/caregiver, patient, and physician factors.

Quality of the studies

Figures S1-S4 demonstrates the quality and risk of bias analyses of the included studies. Of these, 12 were rated as having low quality for ≥2 questions on their appraisals.

Studies assessing barriers to the participation of children with OSA in clinical trials

We identified 14 subcategories of barriers across the studies, which were classified as objective, provider, and patient/caregiver factors. Most of the studies (89.28%) reported objective barriers. Twenty-two studies reported stringent eligibility criteria as a major barrier (14,16-23,25-28,30,33-35,37-41). Other causes include language barriers (17,25,26,33,34), duration (22,29), technical inadequacies (22,23,27,29,30,32,39,41), and the need for emergency/other treatments (14,16,17,34,36,40-42). The details are presented in Table 2.

Six studies reported on provider barriers (15,17,25,26,36,37). One study found that surgeon consensus was in favor of surgery rather than medical treatment during follow-up, possibly changing the treatment (17). Five studies reported other barriers (15,25,26,36,37), such as another surgical method during the study (25), late contact (37), and pharmacy/study personnel errors (15,26,36).

Twenty-five studies reported patient/caregiver barriers (14,16-28,30,31,33-41), including disagreement on or rejection of the treatment (18,19,21-23,26,28,31,33-35,38,39), preferences for another treatment (18,25,31,37,38), and refusion to follow-up (14,16,20,21,23,26-28,31,33-35,38,39). Other identified barriers were transportation issues (24,29,32,39), polysomnography (PSG) tolerability (14,30,33,38), and health problems include congenital diseases or cognitive disorders (16-18,20,23-25,28,30,31,33-36,38,40,41).

Discussion

Key findings

To the best of our knowledge, this study represents the first systematic review of the barriers and interventions related to children with OSA. Our analysis identified 28 relevant studies that examined obstacles hindering the participation of children with OSA in clinical trials, with barriers generally categorized into subjective and objective factors. It should be noted that among the barriers identified in this study, some appear to be across various pediatric clinical trials, such as consent form language, transportation difficulties, and refusal of follow-up. However, some barriers are specific to pediatric OSA, including provider preference for surgery, PSG technical inadequacies and child intolerance. Therefore, when developing solutions, priority should be given to interventions targeting these barriers.

Owing to the paucity of studies investigating potential solutions to these obstacles, adequate strategies to promote the participation of children with OSA in clinical trials remain underdeveloped. To address these challenges, we propose the following underutilized solutions to enhance the inclusion of children with OSA in clinical trials.

Broaden eligibility criteria

Our findings highlight the rigid eligibility criteria as a major structural barrier to children’s access to the available trials. First, conducting clinical trials involving children presents numerous hurdles, including ethical considerations, practical obstacles, and financial constraints (42,43). Second, researchers are required to implement specialized procedures, and disagreements can occur when evaluating whether a child has autonomy to consent to involvement (44). To address this problem, investigators should engage with caregivers and paedologists to better understand the requirements of children when designing trials. One initiative to address this challenge has been the establishment of the IDeA States Pediatric Clinical Trials Network (ISPCTN) in Kansas (45), which aims to develop systematic approaches for evaluating and generating clinical research opportunities for pediatric populations across the United States. However, implementing these initiatives requires strategic planning and execution.

Another factor also known to influence trial participation is language (46). A proportion of participants or their guardians may have had difficulty comprehending the study protocol information. Concurrently, researchers may have been unwilling to allocate sufficient time to explain the study protocol in detail, resulting in the exclusion of otherwise eligible participants. To date, no comprehensive solution has been developed to address this problem. One potential approach would be to establish multilingual research teams to better facilitate communication and improve participant inclusion.

Addressing subject barriers

In addition to structural barriers, attention should also be paid to subject barriers. Our findings highlight the practical impediments, such as time constraints, inadequate transportation, lack of interest, and cost, which limit the participation of children and their families in clinical trials (44). Providing medications not covered by insurance, ensuring free transportation, compensating for time and travel, and offering alternatives, such as telehealth, may increase the willingness to participate in clinical trials.

Moreover, children and their caregivers may be more likely to participate in cohort studies than in RCT, as they may not be eligible for therapy intervention in RCT (47). On the other hand, legal guardians involved in pediatric clinical trials frequently place strong emphasis on the study results, driven by the desire to see meaningful therapeutic benefits for their child’s condition (48). They will express concerns about the efficacy of the method and the possibility of being assigned to an undesired group, such as the placebo group (49). Besides, in the clinical management of children with OSA, the trade-off between surgery and conservative management is a unique clinical debate, involving special considerations such as perioperative airway risk. When physicians hold a strong preference for surgery, they may be less likely to present conservative treatment options or relevant clinical trial opportunities to eligible families, thereby limiting enrollment in non-surgical trials. Strategies need to be tailored to specific obstacle. For the guardians concerned about placebo assignment, providing clear, plain-language explanations of the scientific necessity of placebo controls and the safeguards in place may alleviate anxiety. For those who prioritize study results and therapeutic benefits, individualized risk-benefit counseling can help guardians understand both the potential benefits and limitations of participation. These strategies aim to prevent subjects from blindly worrying about rejection due to insufficient understanding of clinical trials. Regarding treatment preference issues, we recommend that multidisciplinary consensus conferences be convened to develop evidence-based clinical pathways for children with OSA, clearly defining optimal treatment options based on disease severity and age. Additionally, individualized treatment principles should be emphasized, avoiding a one-size-fits-all preference (50).

Evidence suggests that parents are more open to enrolling their children in clinical trials when recommended by a physician they trust (44). Healthcare providers, including medical and allied health professionals, are essential for helping the public develop a clear and accurate perception of clinical trials.

Expanding the reach of clinical trials

Many children who are at high risk for sleep-disordered breathing are excluded from participating in some trials because they are considered frail (51). This exclusion, however, may not necessarily represent methodological bias. Rather, it may reflect appropriate selection constraints or clinical safeguards based on complex physiological and perioperative risks, as well as ethical considerations in protecting higher-risk pediatric populations. Investigators may also be cautious when approaching children who are uncooperative or have communication difficulties, as these factors may compromise study procedures or data integrity (52). Evidence shows that OSA occurs at higher rates and greater severity in children with Down syndrome (53). Some studies have indicated that children with cleft palate have a higher risk of OSA than those without cleft palate (54). Thus, carefully broadening eligibility criteria to increase the enrollment of children with comorbidities while balancing patient safety is a promising solution (55). Virtually, these categories of clinical trials could investigate whether the novel therapeutic interventions are applicable to more clinically diverse patient populations and are feasible for broad implementation (56). To facilitate the implementation of these trials, appropriate strategies should be established to enhance collaboration between researchers and guardians, ensuring that study protocols are adaptable to the participation of medically vulnerable children while addressing their specific needs (57).

According to our findings, assistance from policy and financial aid can promote their participation (58). One solution is Medicaid & Children’s Health Insurance Program (CHIP) in the United States, which provides coverage for cleft palate repair surgeries and related treatments for respiratory apnea for low-income families (59). We hope that a more inclusive medical environment will improve the evidence for diagnosing and treating OSA in children, including those with special needs and comorbidities.

Resolving technical inadequacies

Technical inadequacies in trials include incomplete data, missing or poor signals in PSG, and study personnel errors. Among these, PSG technical inadequacies and child intolerance represent a barrier specific to children with OSA. Owing to the poor compliance among children, the application of wearable devices faces unique challenges. Some studies have highlighted barriers to obtaining PSG data, primarily because of the limited tolerability of PSG equipment in children (14,30,33,38). Children with OSA often present with sleep disruption, daytime sleepiness, and behavioral dysregulation, which compromise their tolerance of electrode placement and unfamiliar sleep laboratory environments, leading to compromised PSG data quality and completeness, and thereby contributing to these technical difficulties. Bedi et al. (60) reported that each additional complication linked to noninvasive ventilation correlated with an 8.7% decline in the likelihood of maintaining long-term therapy. Children undergoing treatment may face various obstacles, including skin irritation on the face, ill-fitting masks, air leakage, resistance to therapy, nasal issues, equipment failures, and abdominal swelling (61,62). Such problems not only hinder treatment compliance, but also elevate the risk of suboptimal clinical outcomes. Owing to the limitations of a standardized approach, there is a critical need to design a broad spectrum of personalized solutions. Healthcare providers should be prepared to tailor these approaches flexibly to align them with the unique needs of pediatric patients and their families. Priority should be given to child-friendly adaptations, such as establishing child-friendly sleep laboratory environments, providing desensitization training prior to PSG, and using simplified lead sets where appropriate. Moreover, to prevent data corruption or loss due to operational mishandling, oversight of technical equipment and data handling processes should be assigned to experienced specialists or personnel with advanced training.

Leveraging real-world data

It is essential to increase the utilization of real-world data, which include a larger number of pediatric patients, to address the evidence gap regarding OSA caused by limitations in clinical trials (63). Such data can be retrospectively examined using diverse sources such as extensive population-based observational studies. For instance, real-world data derived from electronic health records (EHRs) or other health information technology platforms [e.g., Pediatric Health Information System (PHIS) or NICHD Data and Specimen Hub (DASH)] that consolidate information from multiple EHR systems across different clinical settings may play a critical role in closing these evidence gaps (64,65). Pediatric researchers should collaborate with diverse stakeholders to create a structured approach for incorporating real-world data into clinical studies, while also evaluating the advantages and constraints associated with such information. Future efforts are needed to enhance the collection and integration of these data as standard elements for EHRs and other extensive population-based studies.

Strengths and limitations

The present study has several strengths. First, to our knowledge, this is the first systematic review to synthesize the literature on barriers to participation of children with OSA in clinical trials and discuss strategies to overcome them. Second, this study combined these barriers and classified them to propose targeted measures for each subcategory.

This study has several limitations. First, a meta-analysis could not be conducted owing to the diverse nature of data across studies. Thus, our analysis was limited to qualitative synthesis of the data. Second, we investigated trials purposely designed for children rather than for the general population, possibly leading to a focus on the evidence base per se but not the strategies aimed at improving clinical trial enrollment. Finally, we discussed the barriers to participation but did not analyze the potential causes of these issues.

Conclusions

Our findings emphasize that promoting the participation of children with OSA in clinical trials is relevant to all providers, patients, parents, and caregivers. Therefore, we propose that providers should focus on promoting and encouraging pediatric patients and their families to participate in clinical trials. Additionally, formal, targeted strategies should be developed to provide data and technical support for the development of diagnosis and treatment standards specific to children with OSA, ensuring that all children receive specific, evidence-based, and high-quality therapy.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0399/rc

Peer Review File: Available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0399/prf

Funding: This work was supported by Scientific Research Project of the Municipal Bureau of Science and Technology of Shenyang Province (No. 2024-J-3-91-R06).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tp.amegroups.com/article/view/10.21037/tp-2026-0399/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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