CPAP for Obstructive Sleep Apnea

(SPARTA Trial)

Recruiting at 1 trial location

Overseen By Mina Chung, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Valvular abnormalities, Central sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 13 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if using a CPAP machine (a device that aids breathing during sleep) can reduce issues related to atrial fibrillation (a heart rhythm problem) and improve the quality of life for individuals with obstructive sleep apnea (a sleep disorder that interrupts breathing). Participants will alternate between using the CPAP and not using it over several weeks to identify the more effective approach. The trial seeks individuals with both moderate to severe obstructive sleep apnea and a high burden of paroxysmal atrial fibrillation (frequent episodes). As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance treatment options for others with similar conditions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that CPAP is safe for treating obstructive sleep apnea?

Studies have shown that Continuous Positive Airway Pressure (CPAP) is a well-known treatment for obstructive sleep apnea (OSA). Research indicates that it reduces breathing interruptions during sleep and improves the quality of life for individuals with moderate to severe OSA.

Most people adjust to CPAP, though some may experience side effects. Common issues include discomfort from wearing the mask and a dry mouth or nose. One study found a slightly higher risk of throat infections for users. However, these side effects are usually manageable.

Overall, CPAP is widely used and has a strong safety record. Prospective trial participants can feel confident in its established use for treating OSA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

CPAP (Continuous Positive Airway Pressure) for obstructive sleep apnea is unique because it involves a personalized approach where patients alternate between using the CPAP machine and having no treatment at all. This method allows individuals to serve as their own control, helping researchers better understand the direct effects of CPAP on reducing atrial fibrillation burden and improving quality of life. Unlike standard treatments that typically involve consistent use or medications, this alternating protocol offers valuable insights into how intermittent CPAP use can impact health outcomes.

What evidence suggests that CPAP is effective for reducing atrial fibrillation in patients with obstructive sleep apnea?

Studies have shown that Continuous Positive Airway Pressure (CPAP) can improve life quality for people with moderate to severe obstructive sleep apnea (OSA). CPAP keeps the airway open during sleep, reducing the risk of heart problems and other serious health issues. Research indicates that regular CPAP use lowers the chance of major heart events, such as heart attacks. Additionally, using CPAP for at least four hours each night is linked to a decrease in death rates. Overall, CPAP is a well-supported treatment that can lead to better health for those with OSA. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients with moderate to severe obstructive sleep apnea who also have atrial fibrillation. It's designed to see if using CPAP (a machine that helps with breathing at night) can reduce heart rhythm problems and improve life quality related to AF.

Inclusion Criteria

Informed consent

Implanted device with atrial diagnostics

Enrolled in remote monitoring

Exclusion Criteria

Recent device implantation (<6 months)

I have heart valve problems.

I am planning to undergo ablation treatment during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo alternating 2-week periods of CPAP treatment and no treatment over approximately 13 weeks

13 weeks

Visits at baseline, week 4, week 8, and final visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CPAP

Trial Overview The SPARTA trial is testing whether personalized use of CPAP therapy can lessen the occurrence of atrial fibrillation episodes in individuals with OSA. This pilot study uses an N-of-1 design, meaning each participant's response to the intervention is closely monitored over time.

How Is the Trial Designed?

Group I: Alternating CPAP vs. No Treatment Experimental Treatment 1 Intervention

Each participant undergoes alternating 2-week periods of CPAP treatment and no treatment over approximately 13 weeks. This personalized intervention evaluates changes in AF burden and quality of life, with patients serving as their own controls.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5436801/

IMPACT OF CONTINOUS POSITIVE AIRWAY PRESSURE ... We found that long-term improvement in quality of life occurs with the use of CPAP in persons with severe and possibly moderate sleep apnea.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590041224000151

Continuous positive airway pressure treatment for ... This is consistent with previous data showing that optimal CPAP adherence is associated with reduced risk of major adverse cardiovascular events [6] and road ...

3. cjrt.ca cjrt.ca/article/92080-positive-airway-pressure-therapy-adherence-and-outcomes-in-obstructive-sleep-apnea-an-exploratory-longitudinal-retrospective-randomized-chart-review

Positive airway pressure therapy adherence and outcomes ... Observational studies have found a significant reduction in mortality with four or more hours per night of PAP therapy compared to no usage9–12; ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823539

Positive Airway Pressure, Mortality, and CV Risk in Older ... In this cohort study of Medicare beneficiaries with OSA, PAP utilization was associated with lower all-cause mortality and MACE incidence.

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10740

Effects of continuous positive airway pressure on cardiac ... Conclusions: CPAP therapy might prevent subsequent MACEs and all-cause death among patients with moderate to severe obstructive sleep apnea and concomitant ...

6. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=204

Continuous Positive Airway Pressure (CPAP) Therapy for ... Coverage of CPAP is initially limited to a 12 week period for beneficiaries diagnosed with OSA as subsequently described.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212534524000790

Assessment and management of continuous positive ... CPAP is a highly effective treatment for OSA and is supported by extensive evidence of its efficacy in reducing apneas, alleviating symptoms, and addressing ...

8. atsjournals.org atsjournals.org/doi/10.1164/rccm.201307-1282ST

Continuous Positive Airway Pressure Adherence Tracking ... Newer CPAP machines can track adherence, hours of use, mask leak, and residual apnea–hypopnea index (AHI). Such data provide a strong platform to examine OSA ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/resp.13808

Clinical side effects of continuous positive airway pressure ... In one study, OSA patients using CPAP therapy either with or without heated humidity had increased risk of upper airway infections compared to ...