Recruiting

PAP

Sponsor:

Lena Xiao

Code:

NCT07176767

Conditions

Sleep Apnea, Obstructive

Insomnia

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Positive airway pressure therapy

Study Details

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

Study ID

NCT07176767

Start date

Jun 12, 2025

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

82 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Positive airway pressure therapy

Initiation of continuous or bilevel positive airway pressure therapy

Primary outcome measure

  • Mean minutes of nightly PAP usage [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Lena J Xiao, MD MSc

6048752345lena.xiao@cw.bc.ca

Macyn LY Leung, MSc

6048752345macyn.leung@bcchr.ca

Locations

British Columbia Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Lena J Xiao, MD MSc

6048752345lena.xiao@cw.bc.ca

Macyn LY Leung, MSc

6048752345macyn.leung@bcchr.ca

Principal Investigator:

Lena J Xiao, MD

More Information

Sponsor

Lena Xiao

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lena Xiao on 2025-09-23.