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Completed

NCT Number: NCT05949164

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Central Sleep Apnea Dyssomnias Hypoventilation Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Central Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Participant Inclusion Criteria

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

  • Children aged 4-17 years old
  • 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:

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

Treatment and study plan

Insomnia

Behavioral

The primary exposure is insomnia

Primary outcomes

  1. PAP therapy adherence

    Time frame: 6 months

    PAP therapy adherence measured as the mean minutes of nightly PAP usage over 6 months

Secondary outcomes

  1. PAP therapy adherence

    Time frame: 6 months

    PAP therapy adherence expressed as a percentage of total sleep time

  2. PAP therapy adherence

    Time frame: 3 months

    PAP therapy adherence measured as the mean minutes of nightly PAP usage over 3 months

  3. PAP therapy adherence

    Time frame: 3 months

    PAP therapy adherence expressed as a percentage of total sleep time

  4. PAP therapy adherence

    Time frame: 2 weeks

    PAP therapy adherence measured as the mean minutes of nightly PAP usage over 2 weeks

  5. PAP therapy adherence

    Time frame: 2 weeks

    PAP therapy adherence expressed as a percentage of total sleep time

  6. PAP therapy adherence

    Time frame: 3 months

    PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 4 hours per night for 70% of nights)

  7. PAP therapy adherence

    Time frame: 3 months

    PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 6 hours per night for 70% of nights)

  8. PAP therapy adherence

    Time frame: 6 months

    PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 4 hours per night for 70% of nights)

  9. PAP therapy adherence

    Time frame: 6 months

    PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 6 hours per night for 70% of nights)

  10. Physical Well-being (percentage rank)

    Time frame: 1 week

    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.

  11. Psychological Well-being (percentage rank)

    Time frame: 1 week

    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".

  12. Autonomy and Parent Relation (percentage rank)

    Time frame: 1 week

    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.

  13. Self-Perception (percentage rank)

    Time frame: 1 week

    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.

  14. Social Support and Peers (percentage rank)

    Time frame: 1 week

    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.

  15. Daytime Sleepiness

    Time frame: 1 month

    The Epworth Sleepiness Scale is scored from 0-24, with higher scores indicating greater sleepiness.

  16. Depressive Symptoms (T-score)

    Time frame: 7 days

    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).

  17. Depressive Symptoms (T-score)

    Time frame: 7 days

    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).

  18. Anxiety Symptoms (T-score)

    Time frame: 7 days

    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).

  19. Anxiety Symptoms (T-score)

    Time frame: 7 days

    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).

  20. Chronotype

    Time frame: 4 week

    Measured with the Children's Chronotype Questionnaire. The chronotype categorizations including morningness, eveningness, and neither.

  21. Chronotype

    Time frame: 4 week

    Measured with the Reduced Morningness-Eveningness questionnaire. The chronotype categorizations including morningness, eveningness, and neither.

  22. Chronotype

    Time frame: 4 week

    Measured with the Munich Chronotype Questionnaire for Children and Adolescents. The chronotype categorizations including morningness, eveningness, and neither.

  23. Mid-Sleep Point

    Time frame: 4 week

    Measured with the Munich Chronotype Questionnaire for Children and Adolescents

  24. Mid-Sleep Point

    Time frame: 4 week

    Measured with the Children's Chronotype Questionnaire

  25. Sleep Hygiene (total score)

    Time frame: 1 month

    The Adolescent Sleep Hygiene Scale total score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

  26. Sleep Hygiene (Physiological Factor)

    Time frame: 1 month

    Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

  27. Sleep Hygiene (Behavioral Arousal Factor)

    Time frame: 1 month

    Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

  28. Sleep Hygiene (Cognitive/Emotional Factor)

    Time frame: 1 month

    Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

  29. Sleep Hygiene (Sleep Environment Factor)

    Time frame: 1 month

    Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

  30. Sleep Hygiene (Sleep Stability Factor)

    Time frame: 1 month

    Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

  31. Sleep Hygiene (Daytime Sleep Factor)

    Time frame: 1 month

    Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

  32. Sleep Hygiene (Substances Factor)

    Time frame: 1 month

    Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

  33. Sleep Hygiene (Bedtime Routine Factor)

    Time frame: 1 month

    Subscale from the Adolescent Sleep Hygiene Scale total score. The score ranges from 1-6. Higher scores indicate better success with sleep hygiene.

  34. Adherence Barriers to CPAP

    Time frame: 2 weeks

    The score range for the Adherence Barriers to CPAP Questionnaire is 31-155. Higher scores indicate more barriers.

  35. Total Difficulties Score

    Time frame: 6 months

    The Strengths and Difficulties Questionnaire generates a total difficulties score ranging from 0-40, with higher scores indicating greater behavioral difficulty.

  36. Emotional Problems Score

    Time frame: 6 months

    The Strengths and Difficulties Questionnaire generates an emotional problems score ranging from 0-10, with higher scores indicating greater difficulty.

  37. Conduct Problems Score

    Time frame: 6 months

    The Strengths and Difficulties Questionnaire generates a conduct problems score ranging from 0-10, with higher scores indicating greater difficulty.

  38. Hyperactivity Score

    Time frame: 6 months

    The Strengths and Difficulties Questionnaire generates a hyperactivity score ranging from 0-10, with higher scores indicating greater difficulty.

  39. Peer Problems Score

    Time frame: 6 months

    The Strengths and Difficulties Questionnaire generates a peer problems score ranging from 0-10, with higher scores indicating greater difficulty.

  40. Prosocial Score

    Time frame: 6 months

    The Strengths and Difficulties Questionnaire generates a prosocial score ranging from 0-10, with higher scores indicating greater prosocial behavior.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Acronym: IPAd

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 17, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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