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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether early diagnosis of OSA and initiation of and adherence to CPAP therapy in patients hospitalized for chronic obstructive pulmonary disease reduce 30-day hospital readmission rates.

Research Team

Dennis Hwang, MD

Principal Investigator

Kaiser Permanente, Fontana Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+