Prevalence of OSA in COPD and the Clinical Impact of OSA Diagnosis and Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- 30-Day Hospitals Readmissions for COPD
研究概览
简要总结
COPD is a major cause of morbidity and mortality and is characterized by breathing impairment and related symptoms. Obstructive sleep apnea (OSA) is a highly prevalent condition that adversely affects breathing during sleep. The co-occurrence of OSA and COPD in an individual has been referred to as the overlap syndrome (OVS). Regardless of whether OVS represents a single unique entity or two separate conditions in the same patient, the combined respiratory derangements of OSA and COPD are felt to be synergistic. Patients with COPD and OSA may have more frequent and severe nocturnal arterial hypoxemia and hypercapnia than in patients with OSA alone, as well as increased pulmonary hypertension and dysrhythmias. The reported prevalence of OSA in COPD varies widely depending on patient setting, COPD severity, diagnostic methodology, etc., ranging from 10 to 75%. The presence of OSA in patients with COPD has also been implicated as a risk factor for COPD exacerbations and associated hospitalizations.
The coexistence of OSA and COPD is associated with increased risk of COPD exacerbation and shorter time to first exacerbation following diagnosis. 20% of patients discharged following an exacerbation of COPD are readmitted within 30 days, usually for respiratory-related problems.
A randomized controlled trial on Gagnon 3 at Morristown Medical Center will be conducted to diagnose OSA in patients admitted with AECOPD. The WatchPAT One device will be used and can detect the presence of OSA. If OSA is diagnosed, the patient will then be offered and prescribed a home CPAP for use after hospital discharge. We will investigate 30-day of AECOPD readmission rates.
详细描述
- The initial phase of the study will be a prospective cohort design to determine the prevalence of OSA in outpatients with stable COPD who are part of the Atlantic Medical Group/ Pulmonary and Allergy Associates. Home sleep apnea testing will be performed using WatchPAT on consecutive, unselected outpatients with COPD (GOLD stage 3 or 4) who are being managed in an office setting. Inclusion criteria will include age 18 or greater, ability to participate and known dx of COPD with GOLD stage 3 or 4.
- A second phase of our trial will determine OSA prevalence in hospitalized patients admitted with AECOPD who are part of the Atlantic Medical Group/ Pulmonary and Allergy Associates (AMG/PAA). This observational cohort will include both new admissions and 30-day readmissions. Inclusion criteria will include a primary admitting diagnosis of AECOPD, age 18 or greater, ability to participate and known dx of COPD with GOLD stage 3 or 4.
- A third study phase will enroll COPD patients admitted to the pulmonary care unit of Morristown Medical Center and Overlook Medical Center under AMG / PAA. This phase will randomize diagnostic testing and initiate CPAP treatment in those testing positive for OSA. We will then determine CPAP treatment in those with COPD and OSA has an impact on subsequent 30-day hospital readmissions.
Inclusion criteria for this phase of our study will include an admission diagnosis of AECOPD, age greater than 18 years, ability to participate in a portable sleep monitoring study, known COPD diagnosed by a pulmonologist (defined by GOLD, GOLD stage 3 or 4. Standard care patients will not be tested for OSA and will receive routine clinical management as per their treating physicians based on the GOLD Criteria. Consented patients will undergo group randomization to either standard AECOPD care or to overnight sleep apnea testing with the WatchPAT (Itamar Medical, Israel). If OSA is diagnosed, patients will then be offered and prescribed a home CPAP for use upon hospital discharge. The authors will investigate the percentage of 30- day acute exacerbation of COPD (AECOPD) readmission rates for both patient groups once discharged home.
Questionnaire data will be collected from all participants regarding OSA risk factors, sleepiness, fatigue, quality of life. 4. The primary outcome is reduction in 30-day COPD hospital readmissions. Secondary outcomes include determining the prevalence of OSA in outpatient and hospitalized COPD patients. Tertiary outcomes will relate to CPAP usage and compliance, as well as other measures of sleep quality and quality of life on CPAP.
Timeline of Proposal Pre-study Months 0-6 Study Period Months 6-12 Post-study Months 12-24 IRB Submission Study Enrollment Protocol preparations Finalize Case Report Form Data collection and analysis Data analysis Training sessions for Gagnon 3 at MMC and 10 CD at OMC Ongoing clinical follow-up and management of OSA and COPD Generate hypotheses for future research studies
For the diagnostic phases of the study on out-patients and in-patients, we will include 50-100 patients' total. For the randomization portion of the study, we will include 300 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria include GOLD stage 3 or 4 for outpatients and for in-patients, criteria will include an admission diagnosis of AECOPD, age greater than 18 years, ability to participate in a supine sleep study, known COPD diagnosed by a pulmonologist (GOLD stage 3 or 4). Informed consent will be obtained from each patient. The study population will be composed of patients admitted to Gagnon 3 from the emergency department (ED) and to 10 CD from the ED. All new admissions to Gagnon 3 at MMC and 10 CD at OMC will be screened daily by study personnel for enrollment using the author's inclusion and exclusions criteria. Permission to approach patients and families will be requested from the attending pulmonologist.
排除标准
- •a. List exclusion criteria:
- •We excluded patients unable or unwilling to participate in the home sleep study, medical problems or medications affecting the diagnostic accuracy/application of WatchPAT One (peripheral vascular disease, peripheral neuropathy, alpha blockade), admission to the ICU, finger deformity which prevented adequate sensor application.
结局指标
主要结局
30-Day Hospitals Readmissions for COPD
时间窗: 30 Days
30-Day Hospital Readmissions from the Index COPD Hospital Stay
次要结局
- Diagnosis of OSA(48 hours)
研究者
Matthew Epstein
MD
Atlantic Health System