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

NCT ID: NCT07061171

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-01-01

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.

Conditions

Chronic Heart Failure; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure

Intervention Type: 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.

Herbal Decoction

Intervention Type: 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

Intervention Type: 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

Intervention Type: PROCEDURE

Includes massage techniques applied to the head and occipital region to relax muscles and improve local circulation.

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.

Group Type: ACTIVE_COMPARATOR

Continuous Positive Airway Pressure

Intervention Type: 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.

Interventions

Continuous 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.

Intervention Type: DEVICE

Herbal 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.

Intervention Type: DRUG

Acupuncture

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).

Intervention Type: PROCEDURE

Tuina Massage

Includes massage techniques applied to the head and occipital region to relax muscles and improve local circulation.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weihua Peng

OTHER

Sponsor Role: lead

Responsible Party

Weihua Peng

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fugou County Minzhong Hospital

Zhoukou, Henan, China

Countries

China

Other Identifiers

2023-B058

Identifier Type: -

Identifier Source: org_study_id