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

Obstructive Sleep Apnea Clinical Trial

— IPAd  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949164
• Other study ID #: 1000080572
• Status: Recruiting
• Start date: May 16, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: July 2023
• Source: The Hospital for Sick Children
• Contact: Lena Xiao, MD
• Phone: 416-813-6346
• Email: lena.xiao[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Insomnia
The primary exposure is insomnia

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAP therapy adherence	PAP therapy adherence measured as the mean minutes of nightly PAP usage over 6 months	6 months
Secondary	PAP therapy adherence	PAP therapy adherence expressed as a percentage of total sleep time	6 months
Secondary	PAP therapy adherence	PAP therapy adherence measured as the mean minutes of nightly PAP usage over 3 months	3 months
Secondary	PAP therapy adherence	PAP therapy adherence expressed as a percentage of total sleep time	3 months
Secondary	PAP therapy adherence	PAP therapy adherence measured as the mean minutes of nightly PAP usage over 2 weeks	2 weeks
Secondary	PAP therapy adherence	PAP therapy adherence expressed as a percentage of total sleep time	2 weeks
Secondary	PAP therapy adherence	PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 4 hours per night for 70% of nights)	3 months
Secondary	PAP therapy adherence	PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 6 hours per night for 70% of nights)	3 months
Secondary	PAP therapy adherence	PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 4 hours per night for 70% of nights)	6 months
Secondary	PAP therapy adherence	PAP therapy adherence expressed as a dichotomous outcome (PAP usage for at least 6 hours per night for 70% of nights)	6 months
Secondary	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.	1 week
Secondary	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".	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	Daytime Sleepiness	The Epworth Sleepiness Scale is scored from 0-24, with higher scores indicating greater sleepiness.	1 month
Secondary	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).	7 days
Secondary	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).	7 days
Secondary	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).	7 days
Secondary	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).	7 days
Secondary	Chronotype	Measured with the Children's Chronotype Questionnaire. The chronotype categorizations including morningness, eveningness, and neither.	4 week
Secondary	Chronotype	Measured with the Reduced Morningness-Eveningness questionnaire. The chronotype categorizations including morningness, eveningness, and neither.	4 week
Secondary	Chronotype	Measured with the Munich Chronotype Questionnaire for Children and Adolescents. The chronotype categorizations including morningness, eveningness, and neither.	4 week
Secondary	Mid-Sleep Point	Measured with the Munich Chronotype Questionnaire for Children and Adolescents	4 week
Secondary	Mid-Sleep Point	Measured with the Children's Chronotype Questionnaire	4 week
Secondary	Sleep Hygiene (total score)	The Adolescent Sleep Hygiene Scale total score ranges from 1-6. Higher scores indicate better success with sleep hygiene.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	Adherence Barriers to CPAP	The score range for the Adherence Barriers to CPAP Questionnaire is 31-155. Higher scores indicate more barriers.	2 weeks
Secondary	Total Difficulties Score	The Strengths and Difficulties Questionnaire generates a total difficulties score ranging from 0-40, with higher scores indicating greater behavioral difficulty.	6 months
Secondary	Emotional Problems Score	The Strengths and Difficulties Questionnaire generates an emotional problems score ranging from 0-10, with higher scores indicating greater difficulty.	6 months
Secondary	Conduct Problems Score	The Strengths and Difficulties Questionnaire generates a conduct problems score ranging from 0-10, with higher scores indicating greater difficulty.	6 months
Secondary	Hyperactivity Score	The Strengths and Difficulties Questionnaire generates a hyperactivity score ranging from 0-10, with higher scores indicating greater difficulty.	6 months
Secondary	Peer Problems Score	The Strengths and Difficulties Questionnaire generates a peer problems score ranging from 0-10, with higher scores indicating greater difficulty.	6 months
Secondary	Prosocial Score	The Strengths and Difficulties Questionnaire generates a prosocial score ranging from 0-10, with higher scores indicating greater prosocial behavior.	6 months