The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Positive airway pressure therapy.
- Who it may be relevant to
- Registry conditions: Sleep Apnea, Obstructive, Insomnia. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Device Positive airway pressure therapy
Initiation of continuous or bilevel positive airway pressure therapy
Primary outcome measures
- Mean minutes of nightly PAP usage [Time frame: 90 days]
Secondary outcome measures (12)
- Mean minutes of nightly PAP usage [Time frame: 30, 60 days]
- Self-Reported Sense of Mastery (Caregiver) [Time frame: 0, 90 days]
- Self-Reported Sense of Mastery (Participant) [Time frame: 0, 90 days]
- Self-Reported Psychological Scale (Percentage Rank) [Time frame: 0, 90 days]
- Self-Reported Psychological Scale [Time frame: 0, 90 days]
- Self-Reported Sleep Diary [Time frame: 0, 90 days]
- Caregiver-Reported Insomnia Questionnaire [Time frame: 0, 90 days]
- Self-Reported Insomnia Questionnaire (Participant) [Time frame: 0, 30, 60, 90 days]
- Self-Reported Insomnia Questionnaire (Participant) [Time frame: 0, 30, 60, 90 days]
- Self-Reported Insomnia Questionnaire (Caregiver) [Time frame: 0, 90 days]
- Self-Reported Insomnia Questionnaire (Caregiver) [Time frame: 0, 90 days]
- Self-Reported Chronotype Questionnaire [Time frame: 0, 90 days]
Eligibility criteria
Inclusion criteria
- Children aged 8-18 years old
- Obstructive apnea-hypopnea index ≥ 5/hour on baseline diagnostic polysomnogram (PSG)
- Newly prescribed PAP therapy
Exclusion criteria
1\) Developmental disability precluding ability to answer questionnaires
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- British Columbia Children's Hospital — Vancouver
Identifiers
NCT: NCT07176767 · H25-00289 · 354-FP-24