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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05949164
Acronym
IPAd
Enrollment
216
Registered
2023-07-17
Start date
2023-05-16
Completion date
2025-05-01
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sleep Apnea, Hypoventilation, Obstructive Sleep Apnea

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.

Interventions

BEHAVIORALInsomnia

The primary exposure is insomnia

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
PAP therapy adherence6 monthsPAP therapy adherence measured as the mean minutes of nightly PAP usage over 6 months

Secondary

MeasureTime frameDescription
PAP therapy adherence6 monthsPAP therapy adherence expressed as a percentage of total sleep time
Physical Well-being (percentage rank)1 weekThe Physical Well-being Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating lower physical well-being.
Autonomy and Parent Relation (percentage rank)1 weekThe Autonomy and Parent Relation Well-being Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating lower autonomy.
Self-Perception (percentage rank)1 weekThe Self-Perception Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating lower self-perception.
Social Support and Peers (percentage rank)1 weekThe Social Support and Peers Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating lower social support.
Daytime Sleepiness1 monthThe Epworth Sleepiness Scale is scored from 0-24, with higher scores indicating greater sleepiness.
Depressive Symptoms (T-score)7 daysThe Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v2.0 - Depressive Symptoms Questionnaire generates a T-score. Higher scores indicate increased depressive symptoms (patient-reported questionnaire range 35.2-82.4).
Anxiety Symptoms (T-score)7 daysThe Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Bank v2.0 - Anxiety Questionnaire generates a T-score. Higher scores indicate increased anxiety symptoms (patient-reported questionnaire range 33.5-83.3).
Chronotype4 weekMeasured with the Children's Chronotype Questionnaire. The chronotype categorizations including morningness, eveningness, and neither.
Mid-Sleep Point4 weekMeasured with the Munich Chronotype Questionnaire for Children and Adolescents
Sleep Hygiene (total score)1 monthThe Adolescent Sleep Hygiene Scale total score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Sleep Hygiene (Physiological Factor)1 monthSubscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Sleep Hygiene (Behavioral Arousal Factor)1 monthSubscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Psychological Well-being (percentage rank)1 weekThe Psychological Well-being Scale from the KIDSCREEN-27 questionnaire will be used. The percentage rank range is 0-100, with lower scores indicating a dissatisfaction with life.
Sleep Hygiene (Sleep Environment Factor)1 monthSubscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Sleep Hygiene (Sleep Stability Factor)1 monthSubscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Sleep Hygiene (Daytime Sleep Factor)1 monthSubscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Sleep Hygiene (Substances Factor)1 monthSubscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Sleep Hygiene (Bedtime Routine Factor)1 monthSubscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Adherence Barriers to CPAP2 weeksThe score range for the Adherence Barriers to CPAP Questionnaire is 31-155. Higher scores indicate more barriers.
Total Difficulties Score6 monthsThe Strengths and Difficulties Questionnaire generates a total difficulties score ranging from 0-40, with higher scores indicating greater behavioral difficulty.
Emotional Problems Score6 monthsThe Strengths and Difficulties Questionnaire generates an emotional problems score ranging from 0-10, with higher scores indicating greater difficulty.
Conduct Problems Score6 monthsThe Strengths and Difficulties Questionnaire generates a conduct problems score ranging from 0-10, with higher scores indicating greater difficulty.
Hyperactivity Score6 monthsThe Strengths and Difficulties Questionnaire generates a hyperactivity score ranging from 0-10, with higher scores indicating greater difficulty.
Peer Problems Score6 monthsThe Strengths and Difficulties Questionnaire generates a peer problems score ranging from 0-10, with higher scores indicating greater difficulty.
Prosocial Score6 monthsThe Strengths and Difficulties Questionnaire generates a prosocial score ranging from 0-10, with higher scores indicating greater prosocial behavior.
Sleep Hygiene (Cognitive/Emotional Factor)1 monthSubscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026