Obstructive Sleep Apnea (Moderate to Severe)NCT05499286
A Mindfulness-Based Intervention to Improve CPAP
A study testing Mindfulness Program in people with Obstructive Sleep Apnea (Moderate to Severe) and Obstructive Sleep Apnea, run by The Hospital for Sick Children at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea (Moderate to Severe), Obstructive Sleep Apnea
- What is being tested?
- Mindfulness Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2020to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent age (13-18 years)
- Confirmed diagnosis of moderate or severe OSA
- Adolescent should have the capacity to consent themselves
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mindfulness-Based Intervention to Improve CPAP Adherence in Adolescents With Obstructive Sleep Apnea
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
- Being tested
- Mindfulness Program
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness ProgramOther
Mindful Awareness and Resilience Skills for Adolescents (MARS-A) Curriculum
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Program | Active comparator | Participants will attend an online mindfulness program known as the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) program. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4-12
Secondary outcomes (1)
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.
Measured: Week 4-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start28 Jun 2020
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (Moderate to Severe)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indra Narang, The Hospital for Sick Children
- Investigators
- Indra Narang, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499286
- Sponsor's protocol ID
- 1000068799
- Status last verified
- May 2026
- First submitted
- 25 Apr 2022
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-Based Intervention to Improve CPAP Adherence in Adolescents With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05499286
- Acronym / sponsor ID
- 1000068799
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 28 Jun 2020 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Program | Active comparator | Other: Mindfulness ProgramParticipants will attend an online mindfulness program known as the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescent age (13-18 years)
- Confirmed diagnosis of moderate or severe OSA
- Adolescent should have the capacity to consent themselves
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness ProgramMindful Awareness and Resilience Skills for Adolescents (MARS-A) Curriculum | Other | Mindfulness Program |
Primary outcome
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.
1 secondary outcome
The effects of increased adherence on mental, physical, and psychosocial statuses.
Time frame: Week 4-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indra Narang, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Program in people with Obstructive Sleep Apnea (Moderate to Severe) and Obstructive Sleep Apnea, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of MBI for CPAP adherence. (time frame: Week 4-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.