The IPAD Cohort Study: Insomnia and Positive Airway Pressure Adherence in Children and Adolescents
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-18
SponsorLena Xiao
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 8-18 years old
Obstructive apnea-hypopnea index ≥ 5/hour on baseline diagnostic polysomnogram (PSG)
Newly prescribed PAP therapy
Disqualifiers
None
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Positive airway pressure therapy
DeviceInitiation of continuous or bilevel positive airway pressure therapy
Treatment groups
82 Participants
are divided into 1 treatment groupGroup A: OSA Children Starting PAP1 intervention
Trial outcomes
Primary outcomes
1
Mean minutes of nightly PAP usage
Adherence will be determined objectively using ventilator download data (days 60-90 after PAP initiation)
Time frame
90 daysSecondary outcomes
1
Mean minutes of nightly PAP usage
Adherence will be determined objectively using ventilator download data (days 0-30 and 30-60 after PAP initiation)
Time frame
30, 60 days2
Self-Reported Sense of Mastery (Caregiver)
The self-reported Pearlin Mastery Scale will be used to measure the caregiver's mastery. Scores range from 7 to 28, with higher scores indicating greater levels of mastery.
Time frame
0, 90 days3
Self-Reported Sense of Mastery (Participant)
The self-reported Pearlin Mastery Scale will be used to measure the participant's individual mastery. Scores range from 7 to 28, with higher scores indicating greater levels of mastery.
Time frame
0, 90 days4
Self-Reported Psychological Scale (Percentage Rank)
The self-reported Psychological Scale from the KIDSCREEN-10 questionnaire will be used to measure health-related quality of life. The score ranges from 10-50, with lower scores indicating a "dissatisfaction with life".
Time frame
0, 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lena Xiao
Lead sponsor
University of British Columbia
Sponsor institution
American Academy of Sleep Medicine
Collaborator
The Hospital for Sick Children
Collaborator
Source ClinicalTrials.gov