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Completed

NCT Number: NCT05499286

A Mindfulness-Based Intervention to Improve CPAP

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

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Key information

Conditions

Obstructive Sleep Apnea (Moderate to Severe) Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G 1X9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Program

Other

Mindful Awareness and Resilience Skills for Adolescents (MARS-A) Curriculum

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2022
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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