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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
COPD Readmit Trial 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.Check my eligibility
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.See study design
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.
COPD Readmit Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with COPD when I was last admitted to the hospital.
Select...
I have been diagnosed with obstructive sleep apnea.
COPD Readmit Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital readmission and mortality rates
Secondary outcome measures
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 moreSide effects data
From 2014 Phase 2 trial • 53 Patients • NCT0118777132%
Respiratory tract infections
21%
Drowsy driving
18%
Injuries NEC
14%
Aural disorders NEC
14%
Epidermal and dermal conditions
11%
Gastrointestinal signs and symptoms
11%
Joint disorders
7%
Upper respiratory tract disorders (excl infections)
7%
Headaches
7%
Gallbladder disorders
7%
Tendon, ligament and cartilage disorders
7%
Female reproductive tract infections and inflammations
7%
Respiratory disorders NEC
4%
Anxiety disorders and symptoms
4%
Suicidal and self-injurious behaviors NEC
4%
Gastrointestinal infections
4%
Gastrointestinal motility
4%
Procedural related injuries and complicatins NEC
4%
Glucose metabolism disorders
4%
Genitourinary tract disorders NEC
4%
Medication errors
4%
Bone disorders (excl congenital and fractures)
4%
Ocular infections, irritations and inflammations
4%
Diverticular disorders
4%
Bone and joint injuries
4%
Muscle disorders
4%
Musculoskeletal and connective tissue disorders NEC
4%
Coronary artery disrders
4%
Urinary tract signs and symptoms
4%
Demyelinating disorders
4%
Depressed mood disorders and disturbances
4%
Mood disorders and disturbances NEC
4%
Skin and subcutaneous tissue infections and infestations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Laparoscopic Gastric Banding
Continuous Positive Airway Pressure
COPD Readmit 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
~1680
Find a Location
Who is running the clinical trial?
Kaiser PermanenteLead Sponsor
538 Previous Clinical Trials
24,113,728 Total Patients Enrolled
Dennis Hwang, MDPrincipal InvestigatorKaiser Permanente, Fontana Medical Center
6 Previous Clinical Trials
3,998 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with COPD when I was last admitted to the hospital.I need oxygen therapy or a breathing machine for my chronic lung problem.I have been diagnosed with obstructive sleep apnea.I have a job that requires a commercial driver's license or involves operating heavy machinery.I have sleep apnea that is mainly central, not obstructive.I can undergo a sleep study without needing extra oxygen.I need a tracheostomy.You are a member of Kaiser Permanente.I am 18 years old or older.I am not fluent in English.I have used a CPAP machine in the last 6 months.I often feel very sleepy during the day.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Pathway
- Group 2: CPAP Intervention Pathway
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any vacancies in this investigation for participants?
"This medical trial, which had its last update on July 5th 2022, is not currently recruiting patients. Nonetheless, there are still 749 other studies that require volunteers at the moment."
Answered by AI
Who else is applying?
What site did they apply to?
Sleep Center; San Bernardino County Medical Center, Kaiser Permanente
What portion of applicants met pre-screening criteria?
Did not meet criteria
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