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

NCT07176767 | Recruiting

• 2 other identifiers: H25-00289354-FP-24
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive; Insomnia

Keywords

Obstructive Sleep Apnea; Insomnia; Pediatric Sleep; Positive Airway Pressure Adherence

Outcome Measures

Primary Outcomes (1)

• Mean minutes of nightly PAP usage

  Adherence will be determined objectively using ventilator download data (days 60-90 after PAP initiation)

  90 days

Secondary Outcomes (28)

• Mean minutes of nightly PAP usage

  30, 60 days

• Self-Reported Sense of Mastery (Caregiver)

  0, 90 days

• Self-Reported Sense of Mastery (Participant)

  0, 90 days

• Self-Reported Psychological Scale (Percentage Rank)

  0, 90 days

• Self-Reported Psychological Scale

  0, 90 days

Study Arms (1)

OSA Children Starting PAP

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.

Device: Positive airway pressure therapy

Interventions

Positive airway pressure therapy DEVICE

Initiation of continuous or bilevel positive airway pressure therapy

Also known as: Continuous positive airway pressure therapy, Bilevel positive airway pressure therapy

OSA Children Starting PAP

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from two tertiary care academic hospitals, The Hospital for Sick Children (Toronto, Canada) and British Columbia Children's Hospital (BCCH) (Vancouver, Canada).

You may qualify if:

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

You may not qualify if:

• \) Developmental disability precluding ability to answer questionnaires

Sponsors & Collaborators

• Lena Xiao: lead
• American Academy of Sleep Medicine: collaborator
• The Hospital for Sick Children (SickKids): collaborator

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Lena J Xiao, MD, MSc

  Provincial Health Services Authority British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena J Xiao, MD MSc

CONTACT

6048752345; lena.xiao@cw.bc.ca

Macyn LY Leung, MSc

CONTACT

6048752345; macyn.leung@bcchr.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)