A Mindfulness-Based Intervention to Improve CPAP

May 7, 2026 updated by: Indra Narang, The Hospital for Sick Children

A Mindfulness-Based Intervention to Improve CPAP Adherence in Adolescents With Obstructive Sleep Apnea

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X9
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adolescent age (13-18 years)
  • Confirmed diagnosis of moderate or severe OSA
  • Adolescent should have the capacity to consent themselves

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mindfulness Program
Participants will attend an online mindfulness program known as the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program.
Other: Mindfulness Program
Mindful Awareness and Resilience Skills for Adolescents (MARS-A) Curriculum
No Intervention: Online Peer Support Program
Participants will attend an online peer support program where they will engage with each other by sharing experiences while providing advice and emotional support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effectiveness of MBI for CPAP adherence.
Time Frame: Week 4-12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effects of increased adherence on mental, physical, and psychosocial statuses.
Time Frame: Week 4-12
Evaluate the effects of increased CPAP adherence on daytime sleepiness, HRQOL, psychosocial functioning and mental health status (e.g. anxiety and depression). This will be measured by administering questionnaires at baseline, before intervention, after intervention and again at follow-up.
Week 4-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Indra Narang, MD, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2020

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000068799

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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