An observational study in Obstructive Sleep Apnea, Hypoventilation and Central Sleep Apnea, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by The Hospital for Sick Children · Observational
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.
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 216 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Children and adolescents established on PAP therapy
Participant Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Participant Exclusion Criteria
An individual or caregiver who meets one or more of the following criteria will be excluded from participation in this study:
Children who are deemed by a healthcare professional to be able to answer questionnaires independently (group 1) will be asked to complete self-reported questionnaires. Caregivers will also be asked to complete proxy-reported questionnaires.
Behavioral: Insomnia
The caregivers of children who are deemed by a healthcare professional to be unable to answer questionnaires (group 2) will be invited to complete proxy-reported questionnaires only. There are no self-reported questionnaires for this group.
Behavioral: Insomnia
The primary exposure is insomnia
PAP therapy adherence
PAP therapy adherence measured as the mean minutes of nightly PAP usage over 6 months
Time frame: 6 months
PAP therapy adherence
PAP therapy adherence expressed as a percentage of total sleep time
Time frame: 6 months
PAP therapy adherence
PAP therapy adherence measured as the mean minutes of nightly PAP usage over 3 months
Time frame: 3 months
PAP therapy adherence
PAP therapy adherence expressed as a percentage of total sleep time
Time frame: 3 months
PAP therapy adherence
PAP therapy adherence measured as the mean minutes of nightly PAP usage over 2 weeks
Time frame: 2 weeks
PAP therapy adherence
PAP therapy adherence expressed as a percentage of total sleep time
Time frame: 2 weeks
PAP therapy adherence
PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 4 hours per night for 70% of nights)
Time frame: 3 months
PAP therapy adherence
PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 6 hours per night for 70% of nights)
Time frame: 3 months
PAP therapy adherence
PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 4 hours per night for 70% of nights)
Time frame: 6 months
PAP therapy adherence
PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 6 hours per night for 70% of nights)
Time frame: 6 months
Physical Well-being (percentage rank)
The 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.
Time frame: 1 week
Psychological Well-being (percentage rank)
The 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".
Time frame: 1 week
Autonomy and Parent Relation (percentage rank)
The 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.
Time frame: 1 week
Self-Perception (percentage rank)
The 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.
Time frame: 1 week
Social Support and Peers (percentage rank)
The 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.
Time frame: 1 week
Daytime Sleepiness
The Epworth Sleepiness Scale is scored from 0-24, with higher scores indicating greater sleepiness.
Time frame: 1 month
Depressive Symptoms (T-score)
The 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).
Time frame: 7 days
Depressive Symptoms (T-score)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Bank v2.0 - Depressive Symptoms Questionnaire generates a T-score. Higher scores indicate increased depressive symptoms (proxy-reported questionnaire range 36.2-84.7).
Time frame: 7 days
Anxiety Symptoms (T-score)
The 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).
Time frame: 7 days
Anxiety Symptoms (T-score)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Bank v2.0 - Anxiety Questionnaire generates a T-score. Higher scores indicate increased anxiety symptoms (proxy-reported questionnaire range 34.6-86.4).
Time frame: 7 days
Chronotype
Measured with the Children's Chronotype Questionnaire. The chronotype categorizations including morningness, eveningness, and neither.
Time frame: 4 week
Chronotype
Measured with the Reduced Morningness-Eveningness questionnaire. The chronotype categorizations including morningness, eveningness, and neither.
Time frame: 4 week
Chronotype
Measured with the Munich Chronotype Questionnaire for Children and Adolescents. The chronotype categorizations including morningness, eveningness, and neither.
Time frame: 4 week
Mid-Sleep Point
Measured with the Munich Chronotype Questionnaire for Children and Adolescents
Time frame: 4 week
Mid-Sleep Point
Measured with the Children's Chronotype Questionnaire
Time frame: 4 week
Sleep Hygiene (total score)
The Adolescent Sleep Hygiene Scale total score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Time frame: 1 month
Sleep Hygiene (Physiological Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Time frame: 1 month
Sleep Hygiene (Behavioral Arousal Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Time frame: 1 month
Sleep Hygiene (Cognitive/Emotional Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Time frame: 1 month
Sleep Hygiene (Sleep Environment Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Time frame: 1 month
Sleep Hygiene (Sleep Stability Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Time frame: 1 month
Sleep Hygiene (Daytime Sleep Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Time frame: 1 month
Sleep Hygiene (Substances Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Time frame: 1 month
Sleep Hygiene (Bedtime Routine Factor)
Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.
Time frame: 1 month
Adherence Barriers to CPAP
The score range for the Adherence Barriers to CPAP Questionnaire is 31-155. Higher scores indicate more barriers.
Time frame: 2 weeks
Total Difficulties Score
The Strengths and Difficulties Questionnaire generates a total difficulties score ranging from 0-40, with higher scores indicating greater behavioral difficulty.
Time frame: 6 months
Emotional Problems Score
The Strengths and Difficulties Questionnaire generates an emotional problems score ranging from 0-10, with higher scores indicating greater difficulty.
Time frame: 6 months
Conduct Problems Score
The Strengths and Difficulties Questionnaire generates a conduct problems score ranging from 0-10, with higher scores indicating greater difficulty.
Time frame: 6 months
Hyperactivity Score
The Strengths and Difficulties Questionnaire generates a hyperactivity score ranging from 0-10, with higher scores indicating greater difficulty.
Time frame: 6 months
Peer Problems Score
The Strengths and Difficulties Questionnaire generates a peer problems score ranging from 0-10, with higher scores indicating greater difficulty.
Time frame: 6 months
Prosocial Score
The Strengths and Difficulties Questionnaire generates a prosocial score ranging from 0-10, with higher scores indicating greater prosocial behavior.
Time frame: 6 months
Plan to share: No
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Ran from May 2023 to primary completion in May 2024, 11 months.
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