A Planning Study: Sleep Apnea Intervention for Cardiovascular Disease Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms)
研究概览
简要总结
Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a common health problem that is often associated with loud snoring and sleepiness.The medical term for this problem is obstructive sleep apnea (OSA). People with OSA often have an increased risk for developing heart disease or may already have a diagnosis of heart disease.
A clinical research study is being conducted at Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC) to compare the effects of continuous positive airway pressure (CPAP) to conservative medical therapy with participation in one of four groups:
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Active-PAP Therapy Group (Active-Beh or Active+Beh): Will receive standard medical treatment for sleep apnea with active-PAP. Participants will be randomized to either:
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Active-Pap with respiratory therapist visits only
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Active-Pap with respiratory therapist visits and cognitive behavioral therapist visits.
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Alternative PAP Group (Sham): Will receive lower air delivery level than active-PAP therapy group. Will also have meetings with respiratory therapist.
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Conservative Medical Therapy Group (CMT)*: Will receive a free supply of nasal strips for the duration of their treatment period (either 6 months or 12 months) and follow healthy sleep hygiene guidelines for how to change sleep habits to minimize incidences of apneas (breathing disturbances during sleep). Frequent follow-up support with research coordinator.
A sleep doctor or cardiologist will have indicated that a potential participant is an appropriate candidate to receive PAP or CMT as acceptable approaches to treat his/her sleep apnea. Participants will be recruited between the ages of 45-75 years who have diagnosed heart disease or between 55-75 years for those who have risk factors for developing heart disease.
This is a 6-12 month study** to evaluate alternative ways to address the potential for OSA treatment to reduce heart disease and to identify those features that would strengthen a later, large-scale randomized controlled trial.
We will test the hypothesis that active treatment for OSA with CPAP reduces CVD morbidity and mortality.
*All randomized participants will be given conservative medical therapy (CMT).
**For those randomized after December 31, 2012, follow-up assessment will only be 6 months long
详细描述
In this pilot randomized controlled trial, we will assess the effectiveness of CPAP therapy to reduce the burden of cardiovascular disease (CVD) and CVD risk factors in patients with moderate to severe obstructive sleep apnea (OSA) presenting to a sleep disorders clinic. A total of 700 patients with a new diagnosis of moderate to severe OSA will be recruited from BWH-affiliated sleep disorder clinics, BWH, Massachusetts General Hospital (MGH), and Faulkner Hospital Cardiology Clinics (and similar specialized clinics seeing patients with cardiovascular risk factors, such as endocrinology and hypertensive clinics), Beth Israel Deaconess Medical Center and Joslin Diabetes Center. After completing a 2 week run-in period, randomized participants (approximately 150 participants will be randomized) will undergo baseline and 6 month assessments of key study exposure and outcome variables.
Participants will be randomized after completion of Baseline visit. The treatment arms are as follows:
The active arms are:
- Active-PAP treatment delivered using standard respiratory therapist (RT) adherence education and support. (Active-Beh)
- Active-PAP treatment administered using adherence education and support delivered by a RT and enhanced by a behavioral promotion intervention. (Active+Beh)
The control arms are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstructive apnea hypopnea index (AHI) ≥ 15
- •Age 45-75 years, or 55 to 75 yrs if without established Cardiovascular Disease (CVD)
- •Ability to provide informed consent, with the patient and physician acknowledging accepting uncertainty on the role of PAP in CVD prevention.
- •Established CVD,or having diabetes mellitus, defined by one or more of the following:
- •Prior myocardial infarction
- •Coronary artery revascularization procedure (≥4 months before study entry)
- •Angiographically documented stenosis (>70%) of a major coronary artery
- •Prior ischemic stroke without major functional impairment
- •Diabetes mellitus treated with medication or ≥ 2 fasting glucose levels ≥ 126 mg/dl
- •Three or more of the following established CVD risk factors:
- •Hypertension treated with medications or systolic BP > 140 or diastolic BP > 90 on ≥ 2 occasions
- •Total cholesterol > 240 mg/dl or LDL cholesterol > 160 mg/dl or HDL < 45 mg/dl
- •> 10 pack years of smoking
排除标准
- •Diagnosed heart failure with known cardiac ejection fraction of < 35% or New York Heart Association (NYHA) class 3 or 4 status
- •Less than 4 months since myocardial infarction (MI), stroke or revascularization procedure
- •Poorly controlled hypertension (>170/>100)
- •Prior stroke with functional impairment interfering with ability to complete the protocol
- •Severe uncontrolled medical problems or medications that may influence measurements or impair ability to participate in the study exams (e.g. oral steroids; chronic opioid use; self- reported chronic kidney disease or, if measured, creatinine > 2.5 mg/dl or glomerular filtration rate (GFR) < 30; anemia with Hgb < 10, etc.)
- •Resting oxygen saturation < 90% or nocturnal oxygen saturation <85% for > 10% of the sleep period;
- •Use of prescribed PAP for sleep apnea within the prior 2 years
- •Report of inability to spend >6 hrs in bed
- •Any use of prescribed PAP for sleep apnea
- •Severe sleepiness defined by an Epworth Sleepiness Score of >14 or report of falling asleep driving in the prior 2 years
- •Working as a professional driver
- •Low risk related to having sleep apnea defined by a Berlin Score < 2
- •Central sleep apnea, with >50% of respiratory events classified as central apneas
- •Refusal to consider PAP use after an initial split-night PAP study (pre-randomization)
- •Concurrent involvement in another research study that will result in a conflict as determined by study doctors
结局指标
主要结局
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms)
时间窗: Mean of 6- and 12-months
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Average of changes from baseline to 6 months and from baseline to 12 months.
Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms
时间窗: Mean of 6- and 12-months
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is mean of change from baseline to 6-months and baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.
Difference in CPAP Adherence by Active Treatment Arm
时间窗: 6-months
Adherence to CPAP therapy was tracked remotely by modem transmission. Outcome reported is mean hours of PAP use per night at the 6-month timepoint. Comparison is between those with and without assignment to Motivational Enhancement as part of treatment randomization.
Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms
时间窗: 6-months
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported mean change from baseline to 6-months. Control arms and Active arms were pooled, respectively, for analysis.
Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms
时间窗: 12-months
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. The 2 Active arms and 2 Control arms were pooled to create a 2-arm analysis. Outcome reported is change from baseline to 12-months. Control arms and Active arms were pooled, respectively, for analysis.
Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms)
时间窗: 12-months
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 12-months.
Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms)
时间窗: 6-months
Blood pressure data was collected using a 24-hour ambulatory blood pressure monitor. Outcome reported is mean change from baseline to 6-months.
次要结局
- Ejection Fraction (4 Arm) - 12 Month(12-months)
- Right Ventricular Fractional Area Change (4 Arm) - 12 Month(12-months)
- Change in Epworth Sleepiness Scale (ESS) (4 Arm)(Mean of 6- and 12-months)
- Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm)(Mean of 6- and 12-months)
- Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm)(Mean of 6- and 12-months)
- Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm)(Mean of 6- and 12-months)
- Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm)(Mean of 6- and 12-months)
- Change in Lipid Panel at 6 and 12 Months (4 Arm)(Mean of 6- and 12-months)
- Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm)(Mean of 6- and 12-months)
- Pulmonary Vascular Resistance (4 Arm) - Baseline(12-months)
- End-Diastolic Volume (4 Arm) - 12 Month(12-months)
- Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month(12-months)
- Change in Patient Health Questionnaire (PHQ8) (4 Arm)(Mean of 6- and 12-months)
- Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm)(Mean of 6- and 12-months)
- Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms)(Mean of 6- and 12-months)
- Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline(12-months)
- Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline(12-months)
- Left Atrial Volume Index (4 Arm) - 12 Month(12-months)
- Pulmonary Vascular Resistance (4 Arm) - 12 Month(12-months)
- Change in C-Reactive Protein at Months 6 and 12 (4 Arm)(Mean of 6- and 12-months)
- Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm)(Mean of 6- and 12-months)
- Change in Urine Microalbumin at Months 6 and 12 (4 Arm)(Mean of 6- and 12-months)
- Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm)(Mean of 6- and 12-months)
- End-Diastolic Volume (4 Arm) - Baseline(12-months)
- Ejection Fraction (4 Arm) - Baseline(12-months)
- Right Ventricular Fractional Area Change (4 Arm) - Baseline(12-months)
- Left Ventricular Mass Index (4 Arm) - 12 Month(12-months)
- Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm)(Mean of 6- and 12-months)
- Change in Augmentation Index at Months 6 and 12 (4 Arms)(Mean of 6- and 12-months)
- Left Ventricular (LV) Mass Index (4 Arm) - Baseline(12-months)
- E/Em Lateral Ratio (4 Arm) - Baseline(12-months)
- Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month(12-months)
- E/Em Lateral Ratio (4 Arm) - 12 Month(12-months)
- Left Atrial (LA) Volume Index (4 Arm) - Baseline(12-months)
研究者
Susan Redline
Professor and Senior Physician of Sleep Medicine
Brigham and Women's Hospital