The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents

Lena Xiao

Status: Enrolling

Conditions: Insomnia; Sleep Apnea, Obstructive

Treatments: Device: Positive airway pressure therapy

Study type: Observational

Funder types: Other

Identifiers

NCT07176767

H25-00289

354-FP-24 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children aged 8-18 years old
2. Obstructive apnea-hypopnea index ≥ 5/hour on baseline diagnostic polysomnogram (PSG)
3. Newly prescribed PAP therapy

Exclusion criteria

1) Developmental disability precluding ability to answer questionnaires

Trial design

82 participants in 1 patient group

OSA Children Starting PAP

Description:

Children aged 8-18 years old diagnosed with obstructive sleep apnea (OSA) who are to be initiated on Positive Airway Pressure (PAP) therapy. Children and their caregivers must be willing and able to complete questionnaires about sleep as well as physical and mental health.

Treatment:

Device: Positive airway pressure therapy