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Mindfulness Program for Sleep Apnea
N/A
Recruiting
Led By Indra Narang, BMEDSci, MBBCH, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adolescent age (13-18 years)
Confirmed diagnosis of moderate or severe OSA
Must not have
Known developmental delay such that they are not able to participate in the study
Neuromuscular disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4-12
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare how well a mindfulness-based intervention works compared to online peer support in improving CPAP use for people with sleep apnea.
Who is the study for?
This trial is for teens aged 13-18 with a confirmed diagnosis of moderate or severe Obstructive Sleep Apnea (OSA) who can consent to participate. It's not suitable for those with neuromuscular disorders, limited English proficiency, developmental delays that prevent participation, central sleep apnea, or severe psychiatric conditions.
What is being tested?
The study aims to see if practicing mindfulness can help improve the use of CPAP machines in treating OSA compared to getting support from online peers. Participants will be assigned to either learn mindfulness techniques or join an online peer support group.
What are the potential side effects?
Since this trial involves a non-medical intervention like mindfulness training and peer support groups, there are no direct medical side effects expected. However, participants may experience varying levels of engagement or stress relief.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 13 and 18 years old.
Select...
I have been diagnosed with moderate or severe sleep apnea.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a developmental delay that prevents me from participating in studies.
Select...
I have a neuromuscular disorder.
Select...
I have central sleep apnea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4-12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4-12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The effectiveness of MBI for CPAP adherence.
Secondary study objectives
The effects of increased adherence on mental, physical, and psychosocial statuses.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Mindfulness ProgramActive Control1 Intervention
Participants will attend an online mindfulness program known as the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program.
Group II: Online Peer Support ProgramActive Control1 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.
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
710 Previous Clinical Trials
6,958,094 Total Patients Enrolled
Indra Narang, BMEDSci, MBBCH, MDPrincipal InvestigatorThe Hospital for Sick Children
1 Previous Clinical Trials
20 Total Patients Enrolled
Indra Narang, MDPrincipal InvestigatorThe Hospital for Sick Children
3 Previous Clinical Trials
306 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 13 and 18 years old.I have a developmental delay that prevents me from participating in studies.I have a neuromuscular disorder.I have central sleep apnea.I am a teenager and can make my own medical decisions.I have been diagnosed with moderate or severe sleep apnea.You have been diagnosed with serious mental health issues, like having thoughts of hurting yourself.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness Program
- Group 2: Online Peer Support Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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