The IPAd Study: Exploring the Association Between Insomnia and Positive Airway Pressure Adherence in Children — IPAd  

Obstructive Sleep Apnea Clinical Trial

Official title: The IPAd Study: Exploring the Association Between Insomnia and Positive Airway Pressure Adherence in Children

Status Recruiting

Clinical Trial Summary

Sleep-disordered breathing (SDB) is prevalent in children and adolescents and untreated SDB impacts key indicators of physical and psychosocial health. Positive airway pressure (PAP) therapy is highly effective for the treatment of SDB and is associated with favorable clinical outcomes but is limited by poor adherence. Emerging literature in adults suggests that intolerance to PAP therapy may be related to coexisting insomnia. However, the presence of insomnia in children with known SDB as well as its impact on PAP adherence have not been explored. This proposal will explore the association of coexisting insomnia on PAP adherence in children with SDB using a cross-sectional study design. The investigators will assess the association between insomnia and PAP therapy adherence, measured as the mean minutes of nightly PAP usage over 6 months of use on objective downloads.

Clinical Trial Description

Sleep-disordered breathing (SDB) is prevalent in children and adolescents and untreated SDB impacts key indicators of physical and psychosocial health. Positive airway pressure (PAP) therapy is highly effective for the treatment of SDB and is associated with favorable clinical outcomes but is limited by poor adherence. Emerging literature in adults suggests that intolerance to PAP therapy may be related to coexisting insomnia. This study addresses a critical knowledge gap regarding the association between insomnia and PAP therapy adherence amongst children with SDB. These results will inform future prospective studies on targeted effective interventions to improve PAP adherence in children with SDB. SDB encompasses a range of breathing disorders during sleep including obstructive sleep apnea (OSA), central sleep apnea (CSA), and hypoventilation. PAP therapy is a common treatment modality for SDB that is often implemented after targeted treatment strategies do not fully cure SDB. PAP therapy, which delivers pressurised air via nasal or oronasal interfaces, effectively distends the upper airway to ameliorate OSA and can assist ventilation with pressure support breaths. PAP is highly efficacious when used on a nightly basis and is typically required for many years into adulthood. The use of PAP has been associated with increased survival and improved health-related quality of life in people with neuromuscular disease. However, SDB remains undertreated or untreated in many children due to poor adherence. A deeper understanding of associations with PAP adherence across the diagnostic spectrum may yield greater benefits for all children on PAP therapy. Insomnia is highly prevalent in childhood, occurring in up to 37% of children. Insomnia is associated with reduced cognition and academic functioning as well as reduced health-related quality of life, substance use, and increased risk of psychiatric problems. There is emerging evidence that insomnia commonly coexists with OSA in children. A bi-directional causal relationship likely exists whereby OSA is exacerbated by sleep fragmentation, hyper-arousal, and modified sleep architecture associated with insomnia whereas insomnia symptoms are induced by repeated post-obstruction awakenings in OSA. Of importance is that coexisting insomnia and OSA is associated with greater morbidity than either condition alone. To date, there is minimal reported literature on coexisting insomnia with other SDB including CSA and nocturnal hypoventilation. Although similar pathophysiological mechanisms may exist for CSA, there has been little reported in the literature regarding these relationships. More recently, insomnia has been identified as a risk factor for reduced PAP therapy adherence rates in adult populations due to hypersensitivity to PAP equipment side effects, early discontinuation of therapy, and reduced sleep duration. The impact of insomnia on PAP adherence has never been explored in children. Further, the impact of insomnia on PAP adherence in populations with other SDB diagnoses other than OSA has yet to be explored. Elucidating the impact of coexisting insomnia on PAP adherence may inform future targeted management strategies to improve PAP adherence, such as the addition of cognitive behavioral therapy, and may lead to improved outcomes in children with SDB. ;

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Hypoventilation
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Sleep Apnea, Obstructive

• NCT number: NCT05949164
• Study type: Observational
• Source: The Hospital for Sick Children
• Contact: Lena Xiao, MD
• Phone: 416-813-6346
• Email: lena.xiao@sickkids.ca
• Status: Recruiting
• Start date: May 16, 2023
• Completion date: May 1, 2024