A Mindfulness-Based Intervention to Improve CPAP
1 other identifier
interventional
37
1 country
1
Brief Summary
The main purpose of this study is to assess the effectiveness of a mindfulness-based intervention in improving CPAP use compared to online peer support
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 28, 2020
CompletedFirst Submitted
Initial submission to the registry
April 25, 2022
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedMay 12, 2026
May 1, 2026
4.9 years
April 25, 2022
May 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The effectiveness of MBI for CPAP adherence.
The primary objective is to evaluate the effectiveness of a mindfulness-based intervention (MBI) in improving CPAP adherence in adolescents with OSA when compared to online peer support. Adherence to CPAP will be measured objectively as hours of usage of CPAP per night.
Week 4-12
Secondary Outcomes (1)
The effects of increased adherence on mental, physical, and psychosocial statuses.
Week 4-12
Study Arms (2)
Mindfulness Program
ACTIVE COMPARATORParticipants will attend an online mindfulness program known as the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program.
Online Peer Support Program
NO INTERVENTIONParticipants will attend an online peer support program where they will engage with each other by sharing experiences while providing advice and emotional support.
Interventions
Mindful Awareness and Resilience Skills for Adolescents (MARS-A) Curriculum
Eligibility Criteria
You may qualify if:
- Adolescent age (13-18 years)
- Confirmed diagnosis of moderate or severe OSA
- Adolescent should have the capacity to consent themselves
You may not qualify if:
- Known developmental delay such that they are not able to participate in the study;
- Neuromuscular disorders
- Central sleep apnea
- Known diagnosis of severe psychiatric illnesses (e.g. suicidal ideation)
- Limited knowledge and proficiency in English to complete the study as judged by the clinical team
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Sick Children
Toronto, Ontario, M5G 1X9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Indra Narang, MD
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 25, 2022
First Posted
August 12, 2022
Study Start
June 28, 2020
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
May 12, 2026
Record last verified: 2026-05