CPAP and Physiotherapy for Heart Failure and Sleep Apnea in the Elderly

Weihua Peng

Status: Completed

Conditions: Chronic Heart Failure; Obstructive Sleep Apnea

Treatments: Procedure: Tuina Massage; Drug: Herbal Decoction; Procedure: Acupuncture; Device: Continuous Positive Airway Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT07061171

2023-B058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Study Group: CPAP plus Physiotherapy

Experimental group

Description:

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.

Treatment:

Device: Continuous Positive Airway Pressure

Procedure: Acupuncture

Procedure: Tuina Massage

Drug: Herbal Decoction

Control Group: CPAP Alone

Active Comparator group

Description:

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.

Treatment:

Device: Continuous Positive Airway Pressure