Chronic Heart Failure, Obstructive Sleep Apnea
Conditions
Keywords
Continuous Positive Airway Pressure, Physiotherapy, Elderly, Chronic Heart Failure, Obstructive Sleep Apnea, Sleep Disturbance
Brief summary
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.
Detailed description
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.
Interventions
DEVICEContinuous Positive Airway Pressure
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.
DRUGHerbal Decoction
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.
PROCEDUREAcupuncture
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).
PROCEDURETuina Massage
Includes massage techniques applied to the head and occipital region to relax muscles and improve local circulation.
Sponsors
Weihua Peng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (EF) | 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 Pittsburgh Sleep Quality Index (PSQI) Score | Baseline and 3 months post-treatment | To assess sleep quality. The total score ranges from 0-21, with higher scores indicating poorer sleep quality. |
| Change in Apnea-Hypopnea Index (AHI) | 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) | Baseline and 3 months post-treatment | Measured via arterial blood gas analysis to assess improvement in hypoxemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Longest Apnea Time (LAT) | Baseline and 3 months post-treatment | Measured by polysomnography. |
| Change in Arterial Partial Pressure of Oxygen (PaO2) | Baseline and 3 months post-treatment | Measured via arterial blood gas analysis. |
| Change in End-Diastolic Volume (EDV) | Baseline and 3 months post-treatment | Measured by echocardiography. |
| Incidence of Adverse Reactions | During the 3-month treatment period | Recording of all adverse events experienced during the treatment period, such as nasal itching, nasal dryness, dry eyes, or skin redness. |
| Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2) | Baseline and 3 months post-treatment | Measured via arterial blood gas analysis. |
| Change in End-Systolic Volume (ESV) | Baseline and 3 months post-treatment | Measured by echocardiography. |
| Change in Epworth Sleepiness Scale (ESS) Score | Baseline and 3 months post-treatment | To assess daytime sleepiness. The total score ranges from 0-24, with higher scores indicating greater sleepiness. |
| Change in Lowest Oxygen Saturation (LSaO2) | Baseline and 3 months post-treatment | Measured by polysomnography. |
Countries
China
Outcome results
None listed