A Mindfulness-Based Intervention to Improve CPAP

NCT05499286 | Active Not Recruiting

• 1 other identifier: 1000068799
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 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

Conditions

Obstructive Sleep Apnea (Moderate to Severe); Obstructive Sleep Apnea

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 COMPARATOR

Participants will attend an online mindfulness program known as the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program.

Other: Mindfulness Program

Online Peer Support Program

NO INTERVENTION

Participants will attend an online peer support program where they will engage with each other by sharing experiences while providing advice and emotional support.

Interventions

Mindfulness Program OTHER

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

Mindfulness Program

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X9, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Indra Narang, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

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: September 30, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)