The IPAd Study: Exploring the Association Between Insomnia and Positive Airway Pressure Adherence in Children
Key facts
- Who runs it
- The Hospital for Sick Children
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 216 people enrolled
- Started
- 16 May 2023
- Ended
- 1 May 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- Insomnia
- Record updated
- 21 May 2025
Who can take part
- Age
- 4 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Other criteria
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Group 1: Children able to answer questionnaires independently
Children who are deemed by a healthcare professional to be able to answer questionnaires independently (group 1) will be asked to complete self-reported questionnaires. Caregivers will also be asked to complete proxy-reported questionnaires.
Treatment: Insomnia
- Group 2: Children unable to answer questionnaires
The caregivers of children who are deemed by a healthcare professional to be unable to answer questionnaires (group 2) will be invited to complete proxy-reported questionnaires only. There are no self-reported questionnaires for this group.
Treatment: Insomnia
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 21 May 2025