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Device

CPAP for COPD and Sleep Apnea (COPD Readmit Trial)

N/A

Waitlist Available

Led By Dennis Hwang, MD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary diagnosis upon admission of chronic obstructive pulmonary disease

OSA-predominant (AHI at or above 5) sleep disordered breathing

Must not have

Patients with chronic respiratory failure requiring oxygen therapy or non-invasive ventilation

Commercial driver's license or other occupational hazards (operating heavy machinery)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether earlier diagnosis and treatment of OSA in people hospitalized for COPD can reduce the number of hospital readmissions within 30 days.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

CPAP therapy may cause discomfort such as nasal congestion, dry mouth, skin irritation from the mask, headaches or stomach bloating. However, these side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with obstructive sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have sleep apnea that is mainly central, not obstructive.

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I need a tracheostomy.

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I often feel very sleepy during the day.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital readmission and mortality rates

Secondary study objectives

Chronic Obstructive Pulmonary Disease Assessment Tool (CAT)

Clinic and urgent care visits

Comparing inpatient portable monitor versus 30-day follow up portable monitor results in usual care group

+4 more

Side effects data

From 2014 Phase 2 trial • 53 Patients • NCT01187771

32%

Respiratory tract infections

21%

Drowsy driving

18%

Injuries NEC

14%

Epidermal and dermal conditions

14%

Aural disorders NEC

11%

Gastrointestinal signs and symptoms

11%

Joint disorders

Respiratory disorders NEC

Gallbladder disorders

Female reproductive tract infections and inflammations

Upper respiratory tract disorders (excl infections)

Tendon, ligament and cartilage disorders

Headaches

Diverticular disorders

Muscle disorders

Gastrointestinal infections

Gastrointestinal motility

Suicidal and self-injurious behaviors NEC

Mood disorders and disturbances NEC

Musculoskeletal and connective tissue disorders NEC

Glucose metabolism disorders

Demyelinating disorders

Medication errors

Bone disorders (excl congenital and fractures)

Urinary tract signs and symptoms

Anxiety disorders and symptoms

Depressed mood disorders and disturbances

Genitourinary tract disorders NEC

Procedural related injuries and complicatins NEC

Ocular infections, irritations and inflammations

Bone and joint injuries

Skin and subcutaneous tissue infections and infestations

Coronary artery disrders

100%

80%

60%

40%

20%

Study treatment Arm

Laparoscopic Gastric Banding

Continuous Positive Airway Pressure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CPAP Intervention PathwayExperimental Treatment1 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 PathwayActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Positive Airway Pressure

2016

Completed Phase 3

~1740

0 / 7Eligibility criteria met