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

Status: Completed
Location: See location...
Intervention Type: Behavioral
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 17
Healthy Volunteers: f
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⁃ 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

Locations
Other Locations
Canada
The Hospital for Sick Children
Toronto
Time Frame
Start Date: 2023-05-16
Completion Date: 2025-05-01
Participants
Target number of participants: 216
Treatments
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.
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.
Sponsors
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov