A Mindfulness-Based Intervention to Improve CPAP

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499286
• Other study ID #: 1000068799
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: Jun Au
• Phone: 416-813-6809
• Email: jun.au[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Mindfulness Program
Mindful Awareness and Resilience Skills for Adolescents (MARS-A) Curriculum

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The effects of increased adherence on mental, physical, and psychosocial statuses.	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