Clinical trial NCT05949164: The IPAd Study: Exploring the Association Between Insomnia and Positive Airway Pressure Adherence in Children
Official title: The IPAd Study: Exploring the Association Between Insomnia and Positive Airway Pressure Adherence in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Hypoventilation
Central Sleep Apnea
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 216
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescents established on PAP therapy

Brief 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.

Detailed 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.

Eligibility criteria: Participant Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Children aged 4-17 years old
2. Prescribed PAP therapy for at least 6 months

Participant Exclusion Criteria

An individual or caregiver who meets one or more of the following criteria will be excluded from participation in this study:

1) Limited knowledge and proficiency in English to complete the study as judged by the clinical team.

Primary outcomes:
measure: PAP therapy adherence
timeFrame: 6 months
Secondary outcomes:
measure: PAP therapy adherence
timeFrame: 6 months
measure: PAP therapy adherence
timeFrame: 3 months
measure: PAP therapy adherence
timeFrame: 3 months
measure: PAP therapy adherence
timeFrame: 2 weeks
measure: PAP therapy adherence
timeFrame: 2 weeks
measure: PAP therapy adherence
timeFrame: 3 months
measure: PAP therapy adherence
timeFrame: 3 months
measure: PAP therapy adherence
timeFrame: 6 months
measure: PAP therapy adherence
timeFrame: 6 months
measure: Physical Well-being (percentage rank)
timeFrame: 1 week
measure: Psychological Well-being (percentage rank)
timeFrame: 1 week
measure: Autonomy and Parent Relation (percentage rank)
timeFrame: 1 week
measure: Self-Perception (percentage rank)
timeFrame: 1 week
measure: Social Support and Peers (percentage rank)
timeFrame: 1 week
measure: Daytime Sleepiness
timeFrame: 1 month
measure: Depressive Symptoms (T-score)
timeFrame: 7 days
measure: Depressive Symptoms (T-score)
timeFrame: 7 days
measure: Anxiety Symptoms (T-score)
timeFrame: 7 days
measure: Anxiety Symptoms (T-score)
timeFrame: 7 days
measure: Chronotype
timeFrame: 4 week
measure: Chronotype
timeFrame: 4 week
measure: Chronotype
timeFrame: 4 week
measure: Mid-Sleep Point
timeFrame: 4 week
measure: Mid-Sleep Point
timeFrame: 4 week
measure: Sleep Hygiene (total score)
timeFrame: 1 month
measure: Sleep Hygiene (Physiological Factor)
timeFrame: 1 month
measure: Sleep Hygiene (Behavioral Arousal Factor)
timeFrame: 1 month
measure: Sleep Hygiene (Cognitive/Emotional Factor)
timeFrame: 1 month
measure: Sleep Hygiene (Sleep Environment Factor)
timeFrame: 1 month
measure: Sleep Hygiene (Sleep Stability Factor)
timeFrame: 1 month
measure: Sleep Hygiene (Daytime Sleep Factor)
timeFrame: 1 month
measure: Sleep Hygiene (Substances Factor)
timeFrame: 1 month
measure: Sleep Hygiene (Bedtime Routine Factor)
timeFrame: 1 month
measure: Adherence Barriers to CPAP
timeFrame: 2 weeks
measure: Total Difficulties Score
timeFrame: 6 months
measure: Emotional Problems Score
timeFrame: 6 months
measure: Conduct Problems Score
timeFrame: 6 months
measure: Hyperactivity Score
timeFrame: 6 months
measure: Peer Problems Score
timeFrame: 6 months
measure: Prosocial Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Indra Narang, MD
role: PRINCIPAL_INVESTIGATOR
References: