The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Mean minutes of nightly PAP usage
研究概览
简要总结
Positive Airway Pressure (PAP) is a treatment used to help people with sleep-disordered breathing, particularly those with obstructive sleep apnea (OSA). The device delivers pressurized air through a mask to keep the airways open during sleep, improving breathing and preventing interruptions in sleep.
Studying how insomnia affects PAP adherence in children can help improve future treatments.
However, no long-term studies have looked at this in children. Based on previous research, the investigators plan to conduct a study across multiple centers focusing on children with OSA starting PAP therapy. The study will explore how insomnia affects PAP adherence and how race and ethnicity play a role.
详细描述
The first line of treatment for obstructive sleep apnea (OSA) is positive airway pressure (PAP) therapy, yet children have a less than 50% adherence rate, leaving many undertreated for this condition. Insomnia has been established as a modifiable risk factor for lowering PAP therapy adherence in adults with comorbid insomnia and sleep apnea (COMISA), and research has shown that treating insomnia with cognitive behavioural therapy for insomnia (CBTi) improved PAP adherence in adults. This is an important step forward for improving COMISA treatment outcomes, but cannot yet be applied to children without researching this relationship in paediatric populations. This study will address this research gap by conducting a thorough, in-depth evaluation of the association between paediatric COMISA and PAP adherence. The investigators aim to find whether a causal relationship exists between insomnia and PAP adherence in children with OSA, which has never been assessed longitudinally in children.
This multicenter study will be conducted at two tertiary care academic hospitals: The Hospital for Sick Children (Toronto, Canada) and British Columbia Children's Hospital (BCCH) (Vancouver, Canada). This study will include 82 participants from a diverse population to assess the association between race and ethnicity with PAP therapy adherence, based on previous research showing that being part of a self-identified minority is associated with lower PAP therapy adherence. Participants and caregivers will be asked to complete questionnaires regarding insomnia, sleep behaviour and quality of life at baseline prior to PAP therapy initiation. Electronic follow up questionnaires will be administered at 1, 2, and 3 months after PAP therapy initiation and PAP download data will be completed remotely. The primary objective of this study is to evaluate the impact of baseline insomnia on PAP therapy adherence at 3 months based on self-identified racial and ethnic minority. The results of this study will provide treatment insight and improvement to children with COMISA being treated with PAP therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 8-18 years old
- •Obstructive apnea-hypopnea index ≥ 5/hour on baseline diagnostic polysomnogram (PSG)
- •Newly prescribed PAP therapy
排除标准
- •1) Developmental disability precluding ability to answer questionnaires
结局指标
主要结局
Mean minutes of nightly PAP usage
时间窗: 90 days
Adherence will be determined objectively using ventilator download data (days 60-90 after PAP initiation)
次要结局
- Mean minutes of nightly PAP usage(30, 60 days)
- Self-Reported Sense of Mastery (Caregiver)(0, 90 days)
- Self-Reported Sense of Mastery (Participant)(0, 90 days)
- Self-Reported Psychological Scale (Percentage Rank)(0, 90 days)
- Self-Reported Psychological Scale(0, 90 days)
- Self-Reported Sleep Diary(0, 90 days)
- Caregiver-Reported Insomnia Questionnaire(0, 90 days)
- Self-Reported Insomnia Questionnaire (Participant)(0, 30, 60, 90 days)
- Self-Reported Insomnia Questionnaire (Caregiver)(0, 90 days)
- Self-Reported Chronotype Questionnaire(0, 90 days)
- Caregiver's Self-Reported Chronotype Questionnaire(0, 90 days)
- Self-Reported Daytime Sleepiness Questionnaire(0, 90 days)
- Self-Reported Caffeine Intake Questionnaire(0, 90 days)
- Self-Reported Sleep Hygiene Questionnaire(0, 90 days)
- Caregiver-Reported Global Rating Scale of Change(90 days)
- Self-Reported Global Rating Scale of Change(90 days)
- Self-Reported PAP Adherence Questionnaire(90 days)
- Self-Reported Psychological (Total Anxiety) Subscale(0, 90 days)
- Self-Reported Psychological (Total Depression) Scale(0, 90 days)
- Self-Reported Psychological (Social Phobia) Scale(0, 90 days)
- Self-Reported Psychological (Panic Disorder) Scale(0, 90 days)
- Self-Reported Psychological (Major Depression) Scale(0, 90 days)
- Self-Reported Psychological (Separation Anxiety) Scale(0, 90 days)
- Self-Reported Psychological (Generalized Anxiety) Scale(0, 90 days)
- Self-Reported Psychological (Obsessive-Compulsive) Scale(0, 90 days)
研究者
Lena Xiao
Clinical Assistant Professor
University of British Columbia