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

NCT05949164 | Completed

• 1 other identifier: 1000080572
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea; Hypoventilation; Central Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• PAP therapy adherence

  PAP therapy adherence measured as the mean minutes of nightly PAP usage over 6 months

  6 months

Secondary Outcomes (40)

• PAP therapy adherence

  6 months

• PAP therapy adherence

  3 months

• PAP therapy adherence

  3 months

• PAP therapy adherence

  2 weeks

• PAP therapy adherence

  2 weeks

Study Arms (2)

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.

Behavioral: 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.

Behavioral: Insomnia

Interventions

Insomnia BEHAVIORAL

The primary exposure is insomnia

Group 1: Children able to answer questionnaires independently; Group 2: Children unable to answer questionnaires

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children and adolescents established on PAP therapy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypoventilation; Sleep Apnea, Central

Interventions

Prion Proteins

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Insufficiency; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GPI-Linked Proteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Lipid-Linked Proteins; Membrane Proteins; Prions

Study Officials

• Indra Narang, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 17, 2023
• Study Start: May 16, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)