The Impact of Continuous Positive Airway Pressure Combined With Physiotherapy on Ejection Fraction by Ameliorating Sleep Disturbance and Hypoxemia in Elderly Patients With Chronic Heart Failure and Obstructive Sleep Apnea: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change in Left Ventricular Ejection Fraction (EF)
研究概览
简要总结
This study evaluates whether adding physiotherapy (including herbal medicine, acupuncture, and Tuina massage) to standard continuous positive airway pressure (CPAP) therapy can provide superior benefits compared to CPAP alone for elderly patients suffering from both chronic heart failure (CHF) and obstructive sleep apnea (OSA). This randomized controlled trial aims to determine the combined therapy's efficacy and safety in improving sleep quality, hypoxemia, and cardiac function.
详细描述
The coexistence of chronic heart failure (CHF) and obstructive sleep apnea (OSA) in elderly patients creates a vicious cycle, worsening prognosis. Continuous positive airway pressure (CPAP) is the first-line treatment for OSA, but its efficacy in improving cardiac function in patients with comorbid CHF is debated. This prospective, randomized controlled trial was designed to evaluate the clinical efficacy of a comprehensive intervention combining CPAP with physiotherapy (herbal medicine, acupuncture, and Tuina massage). The study hypothesizes that this combined approach will be more effective than CPAP alone in improving sleep disturbances (assessed by the Pittsburgh Sleep Quality Index and Apnea-Hypopnea Index), alleviating hypoxemia (assessed by arterial blood gas analysis), and favorably modulating left ventricular ejection fraction (EF), thereby offering a superior management strategy for this complex patient population.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CHF according to the New York Heart Association (NYHA) functional classification II-IV.
- •Diagnosis of moderate to severe OSA (Apnea-Hypopnea Index [AHI] > 15 events/hour) confirmed by polysomnography.
- •Age ≥ 65 years.
- •Stable clinical condition for at least one month prior to enrollment.
- •Ability to understand and comply with study procedures and provide informed consent.
排除标准
- •Secondary hypertension.
- •Acute myocardial infarction, congenital heart disease, rapid arrhythmias, significant valvular heart disease, cardiomyopathy, or severe hepatic/renal insufficiency.
- •Other respiratory diseases such as chronic obstructive pulmonary disease (COPD), asthma, or pulmonary hypertension.
- •Use of sedative drugs, morphine or its analogues, or other psychotropic medications; cognitive impairment.
- •Received related treatment for OSA or significant changes in CHF medication within the past month.
- •Withdrawal from the study midway.
- •Current participation in other clinical drug trials.
研究组 & 干预措施
Study Group: CPAP plus Physiotherapy
In addition to receiving the same CPAP therapy as the control group, patients in this arm received a 3-month physiotherapy regimen. The regimen consisted of: 1) Daily oral administration of a modified herbal decoction (Er Chen Tang with Chang Pu Yu Jin Tang); 2) Acupuncture sessions, once daily, 5 times per week; and 3) Head and occipital Tuina massage.
干预措施: Continuous Positive Airway Pressure (Device)
Study Group: CPAP plus Physiotherapy
In addition to receiving the same CPAP therapy as the control group, patients in this arm received a 3-month physiotherapy regimen. The regimen consisted of: 1) Daily oral administration of a modified herbal decoction (Er Chen Tang with Chang Pu Yu Jin Tang); 2) Acupuncture sessions, once daily, 5 times per week; and 3) Head and occipital Tuina massage.
干预措施: Herbal Decoction (Drug)
Study Group: CPAP plus Physiotherapy
In addition to receiving the same CPAP therapy as the control group, patients in this arm received a 3-month physiotherapy regimen. The regimen consisted of: 1) Daily oral administration of a modified herbal decoction (Er Chen Tang with Chang Pu Yu Jin Tang); 2) Acupuncture sessions, once daily, 5 times per week; and 3) Head and occipital Tuina massage.
干预措施: Acupuncture (Procedure)
Study Group: CPAP plus Physiotherapy
In addition to receiving the same CPAP therapy as the control group, patients in this arm received a 3-month physiotherapy regimen. The regimen consisted of: 1) Daily oral administration of a modified herbal decoction (Er Chen Tang with Chang Pu Yu Jin Tang); 2) Acupuncture sessions, once daily, 5 times per week; and 3) Head and occipital Tuina massage.
干预措施: Tuina Massage (Procedure)
Control Group: CPAP Alone
Patients received CPAP therapy using a ResMed S9 AutoSet-S device. An optimal pressure or auto-adjusting range was determined via pressure titration. Patients were instructed to use the device for 5-7 hours per night, at least 5 nights per week, for 3 months. All patients also received standard conventional management for CHF and lifestyle advice.
干预措施: Continuous Positive Airway Pressure (Device)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction (EF)
时间窗: Baseline and 3 months post-treatment
Measured by echocardiography to compare the change in EF from baseline to 3 months post-treatment. EF (%) = (EDV - ESV) / EDV × 100%.
Change in Apnea-Hypopnea Index (AHI)
时间窗: Baseline and 3 months post-treatment
Measured by overnight polysomnography, defined as the total number of apneas and hypopneas per hour of sleep.
Change in Arterial Oxygen Saturation (SaO2)
时间窗: Baseline and 3 months post-treatment
Measured via arterial blood gas analysis to assess improvement in hypoxemia.
Change in Pittsburgh Sleep Quality Index (PSQI) Score
时间窗: Baseline and 3 months post-treatment
To assess sleep quality. The total score ranges from 0-21, with higher scores indicating poorer sleep quality.
次要结局
- Change in End-Diastolic Volume (EDV)(Baseline and 3 months post-treatment)
- Change in End-Systolic Volume (ESV)(Baseline and 3 months post-treatment)
- Change in Epworth Sleepiness Scale (ESS) Score(Baseline and 3 months post-treatment)
- Change in Lowest Oxygen Saturation (LSaO2)(Baseline and 3 months post-treatment)
- Change in Longest Apnea Time (LAT)(Baseline and 3 months post-treatment)
- Change in Arterial Partial Pressure of Oxygen (PaO2)(Baseline and 3 months post-treatment)
- Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2)(Baseline and 3 months post-treatment)
- Incidence of Adverse Reactions(During the 3-month treatment period)
研究者
Weihua Peng
Principal investigator
Fugou County Minzhong Hospital