Effects of Treating Sleep Apnea in Patients With Congestive Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of Hospital Admissions
研究概览
简要总结
Patients with Congestive Heart Failure (CHF) on non-Intensive Care Unit medical services and/or visiting our outpatient Congestive Heart Failure Clinic will be screened using the STOP-BANG Scoring Model. (STOP-BANG stands for Snoring, Tiredness, Observed Apnea, Blood Pressure, Body Mass Index, Age, Neck Circumference, Gender.) Patients with high risk of Obstructive Sleep Apnea (OSA) will be referred for evaluation and treatment of Sleep Apnea. They will be followed to determine if treatment of Sleep Apnea improves their quality of life and decreases their utilization of the Hospital and Emergency Department (ED).
详细描述
Patients with Congestive Heart Failure on non-Intensive Care Unit Medical Services and/or visiting our outpatient Congestive Heart Failure clinic will be screened using the STOP-BANG Scoring Model. Patients with high risk of Obstructive Sleep Apnea will be referred to the Sleep Center physicians for evaluation and treatment. Patients will be followed for one year to determine if the treatment for Sleep Apnea improves their Quality of Life and decreases Hospital and Emergency Department utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has:
- •CHF (systolic, diastolic, any etiology), or
- •Normal Ejection Fraction (EF) and most recent:
- •Age less than 50: N-Terminal Pro Brain Natriuretic Peptide (NTPBNP) > 400,
- •Age 50 and older: NTPBNP > 750,
- •If no NTPBNP done: then Brain Natriuretic Peptide (BNP) > 200 (some newly referred patients will only have this available at their first visit, or
- •Normal EF, no BNP done, and CHF documented in History or Problem List
- •Admitted to the Hospital Medicine service, General Medicine Teaching service, Medicine Cardiology Team (MCT) service, Heart Failure service, or Community Health and Family Medicine (CHFM) service, OR Patient of the Congestive Heart Failure Clinic
- •Patient has had at least 2 encounters (hospital inpatient admission, hospital observation admission, or ED visit) with University of Florida (UF) Health during the 12-month period immediately prior to the current admission (not including the current admission).
- •English Speaking
- •Males & Females
- •Age 18 to 110
- •Agreement to return to Gainesville for regular follow-up visits
排除标准
- •Decisionally impaired, cognitively impaired, or demented patient who has a surrogate, proxy, or guardian
- •Current Drug/Alcohol abuse as evidenced by a) positive urine toxicology screen for cocaine or amphetamines during current admission, b) positive blood alcohol level upon admission, or c) documentation by current providers of continued abuse of alcohol or drugs
- •Previous diagnosis of sleep apnea and on current treatment
- •Uncontrolled Ventricular Dysrhythmias; sustained episodes of ventricular tachycardia or ventricular fibrillation in the hospital
- •Evidence of current ischemia evidenced by elevated Troponin unrelated to Chronic Kidney Disease, or < 6 weeks since Myocardial Infarction (MI)
- •Palliative care or Life expectancy < 6 months
- •Isolated Cor Pulmonale - predominantly right ventricular dysfunction, Right Ventricular Systolic Pressure (RVSP) >50 and/or on the following medications for pulmonary hypertension: sildenafil (Viagra®), tadalafil (Adcirca®, Cialis®), IV or sub-cutaneous (SC) treprostinil (Remodulin®; Tyvaso™), ambrisentan (Letairis®), bosentan (Tracleer®), IV epoprostenol, inhaled iloprost (Ventavis®)
- •On 5 liters or greater of O2
- •Self-Pay Status
- •Known Pregnancy
- •Vulnerable Subjects such as prisoners, decisionally impaired/comatose individuals, terminally ill patients, UF/Shands/Veterans Administration (VA) staff, UF students
研究组 & 干预措施
Patients with Congestive Heart Failure
STOP-BANG Scoring Model
Polysomnogram Sleep Study
干预措施: STOP-BANG Scoring Model (Other)
Patients with Congestive Heart Failure
STOP-BANG Scoring Model
Polysomnogram Sleep Study
干预措施: Polysomnogram Sleep Study (Other)
结局指标
主要结局
Number of Hospital Admissions
时间窗: Compare the number of Hospital Admissions during the 12-month period immediately prior to the index admission to the number of Hospital Admissions during the 12-month period immediately following the study intervention
Number of Hospitalized Days
时间窗: Compare the number of Hospitalized Days during the 12-month period immediately prior to the index admission to the number of Hospitalized Days during the 12-month period immediately following the study intervention
Number of Emergency Department Visits
时间窗: Compare the number of Emergency Department Visits during the 12-month period immediately prior to the index admission to the number of Emergency Department Visits during the 12-month period immediately following the study intervention
次要结局
- Residual Apnea Hypopnea Index(at 12 months)
- % of nights with greater than 4 hours use of Continuous Positive Airway Pressure(at 12 months)
- Epworth Sleepiness Scale(Change from Baseline to 3 months)
- Functional Outcome of Sleep Quality(Change from Baseline to 6 weeks)
- Epworth Sleepiness Scale(Change from Baseline to 12 months)
- Epworth Sleepiness Scale(Change from Baseline to 6 weeks)
- Functional Outcome of Sleep Quality(Change from Baseline to 3 months)
- Functional Outcome of Sleep Quality(Change from Baseline to 12 months)
- Residual Apnea Hypopnea Index(at 6 weeks)
- Residual Apnea Hypopnea Index(at 3 months)
- % of nights with greater than 4 hours use of Continuous Positive Airway Pressure(at 6 weeks)
- % of nights with greater than 4 hours use of Continuous Positive Airway Pressure(at 3 months)