CPAP for COPD and Sleep Apnea

(COPD Readmit Trial)

Overseen By Jessica Arguelles, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Sleep apnea, Respiratory failure, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using CPAP (a machine that helps keep airways open during sleep) can prevent individuals with COPD (a lung disease that makes breathing difficult) and sleep apnea from needing to return to the hospital soon after discharge. Participants will receive either standard care or standard care plus CPAP therapy. Ideal candidates for this trial are those who have been hospitalized for COPD, experience sleep apnea, and have not used CPAP in the last six months. As an unphased trial, this study provides an opportunity to contribute to important research that could enhance future care for COPD and sleep apnea patients.

Will I have to stop taking my current medications?

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 therapy is safe for COPD and sleep apnea patients?

Research has shown that CPAP therapy, commonly used for sleep apnea, is generally safe for individuals with moderate to severe cases. Studies indicate that it can enhance quality of life by alleviating sleep apnea symptoms.

However, caution is advised for those with chronic obstructive pulmonary disease (COPD). Confirming safety is important, as there may be increased risks for these patients. While CPAP is widely used, discussing any concerns with a healthcare provider is crucial, especially for those with COPD.

Regular use of CPAP therapy has been linked to better outcomes, such as reduced daytime sleepiness and improved overall well-being. Many patients tolerate CPAP therapy well, but individual health conditions should be considered. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CPAP therapy for COPD and sleep apnea because it offers a unique approach to managing these conditions. Unlike standard treatments that focus primarily on pharmacotherapy, CPAP therapy delivers continuous positive airway pressure to keep airways open during sleep, which can improve breathing and reduce sleep disruptions. This method is enhanced by wireless connectivity that monitors adherence, allowing for personalized adjustments and support. By combining CPAP with standard care, there is potential for better management of symptoms and reduced hospital readmissions, making it a promising option for patients with COPD and sleep apnea.

What evidence suggests that CPAP therapy might be an effective treatment for COPD and sleep apnea?

Research has shown that CPAP therapy, which participants in this trial may receive, can help individuals with COPD and sleep apnea. One study found that it led to fewer hospital visits for COPD and a lower risk of death. Another study demonstrated that CPAP reduced hospital admissions for those with both COPD and sleep apnea. CPAP provides a steady flow of air to keep airways open during sleep, easing breathing problems. Although some studies have mixed results, the overall evidence suggests that CPAP can make a significant difference. ^{2 6 7 8 9}

Who Is on the Research Team?

Dennis Hwang, MD

Principal Investigator

Kaiser Permanente, Fontana Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are members of Kaiser Permanente, diagnosed with COPD and have OSA-predominant sleep disordered breathing. They must not have used CPAP recently, be non-sleepy (ESS below 11), speak English, and not require oxygen therapy or have other specific health exclusions.

Inclusion Criteria

I was diagnosed with COPD when I was last admitted to the hospital.

I have been diagnosed with obstructive sleep apnea.

I can undergo a sleep study without needing extra oxygen.

Exclusion Criteria

I need oxygen therapy or a breathing machine for my chronic lung problem.

Pregnant patients

I have a job that requires a commercial driver's license or involves operating heavy machinery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Diagnosis

Patients undergo a portable sleep study to diagnose OSA-predominant sleep disordered breathing

During hospitalization

Inpatient

Treatment

Patients with OSA receive CPAP therapy in the hospital followed by home CPAP therapy

30 days

Follow-up at Fontana Sleep Center within 1 month after discharge

Follow-up

Participants are monitored for readmission rates, adherence to CPAP therapy, and presence of symptoms

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CPAP Therapy

Trial Overview The study aims to see if diagnosing OSA early and starting CPAP treatment in hospitalized COPD patients can lower the chances of them being readmitted within 30 days after discharge.

How Is the Trial Designed?

Group I: CPAP Intervention Pathway Experimental Treatment 1 Intervention

Patients will receive continuous positive airway pressure (CPAP) therapy in the hospital followed by home CPAP therapy. Their home CPAP therapy will include wireless connectivity, which includes adherence data. Furthermore, the patients will be entered into our usual automated platform (USleep; ResMed Corp) in which patients with suboptimal CPAP use will be sent messages (based on patient preference) in order to ensure adherence to therapy. This platform is already a standard part of our usual care. The patients will receive CPAP in addition to contemporary standard of care pharmacotherapy for their underlying COPD. They will follow up at the Fontana Sleep Center within 1 month after discharge for assessment of CPAP use and asked to complete a questionnaire packet. Patients will be followed during the 30-day period and assessed for readmission rates, time to readmission, adherence to CPAP therapy, and presence of symptoms.

Group II: Usual Care Pathway Active Control 1 Intervention

Patients will receive contemporary standard of care pharmacotherapy for their underlying COPD condition and will not receive CPAP therapy for the duration of the study. They will be asked to follow up at the Fontana Sleep Center within 1 month after discharge for a repeat outpatient portable sleep study and asked to complete a questionnaire packet. The results of the outpatient portable sleep studies will be compared with the in-patient portable sleep study. Patients will also be asked to follow up with the Fontana Sleep Center within 1 month after discharge for assessment of primary and secondary outcomes. Patients will be followed during the 30-day period and assessed for readmission rates, time to readmission, adherence to CPAP therapy, and presence of symptoms.

CPAP Therapy is already approved in United States, Canada, European Union for the following indications:

Approved in United States as CPAP Therapy for:

• Obstructive Sleep Apnea
• Central Sleep Apnea
• Mixed Sleep Apnea
• Sleep-Related Breathing Disorders

Approved in Canada as CPAP Therapy for:

• Obstructive Sleep Apnea
• Central Sleep Apnea
• Mixed Sleep Apnea
• Sleep-Related Breathing Disorders

Approved in European Union as CPAP Therapy for:

• Obstructive Sleep Apnea
• Central Sleep Apnea
• Mixed Sleep Apnea
• Sleep-Related Breathing Disorders

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9887426/

Impact of Positive Airway Pressure Therapy Adherence on ... One small study showed that treatment with positive airway pressure (PAP) in patients with overlap syndrome reduced chronic obstructive pulmonary disease– ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945723001946

The use of continuous positive airway pressure in COPD ... Our findings revealed that CPAP therapy improved clinical outcomes, including COPD exacerbation, COPD related hospitalization, and mortality in patients with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7139021/

Continuous positive airway pressure improves respiratory ... For non-RF-complicated COPD, CPAP was shown to significantly improve patient survival, and risk of hospital admission in those who also had obstructive sleep ...

4. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00087-2/fulltext

May continuous positive airway pressure (CPAP) treatment ... CPAP treatment would reduce this risk by correcting the hypoxic burden and sleep fragmentation. However, randomized controlled trials failed to ...

5. nature.com nature.com/articles/s41598-025-88834-3

Assessment of continuous positive airway pressure effect ... The study's purpose was to investigate the effect of one-night continuous positive airway pressure treatment (CPAP treatment) on circadian clock genes.

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6374080/

Treatment of Adult Obstructive Sleep Apnea With Positive ... Overall, the analyses support the conclusion that CPAP is effective in reducing OSA severity as measured by the AHI or RDI, across the spectrum of OSA severity.

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

Continuous Positive Airway Pressure (CPAP) Therapy for ... Use this page to view details for the decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2).

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

Continuous Positive Airway Pressure Adherence Tracking ... Increased CPAP adherence has been shown to improve outcomes such as daytime sleepiness, quality of life, and mortality (23–25). OSA should be considered in a ...