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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group: CPAP plus Physiotherapy | Experimental | 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. |
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| Control Group: CPAP Alone | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure | Device | Using a ResMed S9 AutoSet-S device with a pressure range of 4-20 cmH2O. Used for 5-7 hours per night, at least 5 nights per week, for 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (EF) | Measured by echocardiography to compare the change in EF from baseline to 3 months post-treatment. EF (%) = (EDV - ESV) / EDV × 100%. | Baseline and 3 months post-treatment |
| Change in Pittsburgh Sleep Quality Index (PSQI) Score | To assess sleep quality. The total score ranges from 0-21, with higher scores indicating poorer sleep quality. | Baseline and 3 months post-treatment |
| Change in Apnea-Hypopnea Index (AHI) | Measured by overnight polysomnography, defined as the total number of apneas and hypopneas per hour of sleep. | Baseline and 3 months post-treatment |
| Change in Arterial Oxygen Saturation (SaO2) | Measured via arterial blood gas analysis to assess improvement in hypoxemia. | Baseline and 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in End-Diastolic Volume (EDV) | Measured by echocardiography. | Baseline and 3 months post-treatment |
| Change in End-Systolic Volume (ESV) | Measured by echocardiography. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fugou County Minzhong Hospital | Zhoukou | Henan | 461300 | China |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Herbal Decoction | Drug | A daily dose of a decoction containing Ban Xia, Ju Hong, Shi Chang Pu, Yu Jin, Lai Fu Zi, Fu Ling, Bai Zhi, Cang Er Zi, and Gan Cao, administered orally in two divided doses. |
|
| Acupuncture | Procedure | Daily sessions with needle retention for 30 minutes, 5 times per week. Acupoints included Anmian (EX-HN22), Lianquan (CV23), Shanzhong (CV17), Zhongwan (CV12), Kongzui (LU6), Pishu (BL20), Fenglong (ST40), Zusanli (ST36), Yinlingquan (SP9), and Zhaohai (KI6). |
|
| Tuina Massage | Procedure | Includes massage techniques applied to the head and occipital region to relax muscles and improve local circulation. |
|
| Baseline and 3 months post-treatment |
| Change in Epworth Sleepiness Scale (ESS) Score | To assess daytime sleepiness. The total score ranges from 0-24, with higher scores indicating greater sleepiness. | Baseline and 3 months post-treatment |
| Change in Lowest Oxygen Saturation (LSaO2) | Measured by polysomnography. | Baseline and 3 months post-treatment |
| Change in Longest Apnea Time (LAT) | Measured by polysomnography. | Baseline and 3 months post-treatment |
| Change in Arterial Partial Pressure of Oxygen (PaO2) | Measured via arterial blood gas analysis. | Baseline and 3 months post-treatment |
| Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2) | Measured via arterial blood gas analysis. | Baseline and 3 months post-treatment |
| Incidence of Adverse Reactions | Recording of all adverse events experienced during the treatment period, such as nasal itching, nasal dryness, dry eyes, or skin redness. | During the 3-month treatment period |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012138 |
| Respiratory Therapy |
| D000529 | Complementary Therapies |