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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
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.
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.
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).
Fugou County Minzhong Hospital
Zhoukou, Henan, China
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%.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 3 months post-treatment
Change in Arterial Oxygen Saturation (SaO2)
Measured via arterial blood gas analysis to assess improvement in hypoxemia.
Time frame: Baseline and 3 months post-treatment
Change in End-Diastolic Volume (EDV)
Measured by echocardiography.
Time frame: Baseline and 3 months post-treatment
Change in End-Systolic Volume (ESV)
Measured by echocardiography.
Time frame: 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.
Time frame: Baseline and 3 months post-treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Includes massage techniques applied to the head and occipital region to relax muscles and improve local circulation.
Change in Lowest Oxygen Saturation (LSaO2)
Measured by polysomnography.
Time frame: Baseline and 3 months post-treatment
Change in Longest Apnea Time (LAT)
Measured by polysomnography.
Time frame: Baseline and 3 months post-treatment
Change in Arterial Partial Pressure of Oxygen (PaO2)
Measured via arterial blood gas analysis.
Time frame: Baseline and 3 months post-treatment
Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Measured via arterial blood gas analysis.
Time frame: 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.
Time frame: During the 3-month treatment period