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

NCT07061171 | Completed

• 1 other identifier: 2023-B058
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Obstructive Sleep Apnea

Keywords

Continuous Positive Airway Pressure; Physiotherapy; Elderly; Chronic Heart Failure; Obstructive Sleep Apnea; Sleep Disturbance

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (8)

• Change in End-Diastolic Volume (EDV)

  Baseline and 3 months post-treatment

• Change in End-Systolic Volume (ESV)

  Baseline and 3 months post-treatment

• Change in Epworth Sleepiness Scale (ESS) Score

  Baseline and 3 months post-treatment

• Change in Lowest Oxygen Saturation (LSaO2)

  Baseline and 3 months post-treatment

• Change in Longest Apnea Time (LAT)

  Baseline and 3 months post-treatment

Study Arms (2)

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.

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

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.

Device: Continuous Positive Airway Pressure

Interventions

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.

Control Group: CPAP Alone; Study Group: CPAP plus Physiotherapy

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.

Study Group: CPAP plus Physiotherapy

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).

Study Group: CPAP plus Physiotherapy

Tuina Massage PROCEDURE

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

Study Group: CPAP plus Physiotherapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weihua Peng: lead

Study Sites (1)

Fugou County Minzhong Hospital

Zhoukou, Henan, 461300, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Parasomnias

Interventions

Continuous Positive Airway Pressure; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Complementary Therapies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

CN (1)