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A Mindfulness-Based Intervention to Improve CPAP

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness Program
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea (Moderate to Severe)

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mindfulness Program

Online Peer Support Program

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 25, 2022
Last Updated
August 10, 2022
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT05499286
Brief Title
A Mindfulness-Based Intervention to Improve CPAP
Official Title
A Mindfulness-Based Intervention to Improve CPAP Adherence in Adolescents With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2020 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (Moderate to Severe), Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Program
Arm Type
Active Comparator
Arm Description
Participants will attend an online mindfulness program known as the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program.
Arm Title
Online Peer Support Program
Arm Type
No Intervention
Arm Description
Participants will attend an online peer support program where they will engage with each other by sharing experiences while providing advice and emotional support.
Intervention Type
Other
Intervention Name(s)
Mindfulness Program
Intervention Description
Mindful Awareness and Resilience Skills for Adolescents (MARS-A) Curriculum
Primary Outcome Measure Information:
Title
The effectiveness of MBI for CPAP adherence.
Description
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.
Time Frame
Week 4-12
Secondary Outcome Measure Information:
Title
The effects of increased adherence on mental, physical, and psychosocial statuses.
Description
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.
Time Frame
Week 4-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Deonarain
Phone
416-813-6809
Email
christina.deonarain@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Indra Narang
Phone
416-813-6346
Email
indra.narang@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indra Narang, BMEDSci, MBBCH, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Deonarain
Phone
416-813-6809
Email
christina.deonarain@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Indra Narang
Phone
416-813-6346
Email
indra.narang@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Indra Narang, BMedSci, MBBCH, MD

12. IPD Sharing Statement

Learn more about this trial

A Mindfulness-Based Intervention to Improve CPAP

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