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NCT Number: NCT07061171

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

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.

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Key information

Conditions

Chronic Heart Failure Apnea Dyssomnias Mental Disorders Nervous System Diseases Obstructive Sleep Apnea Parasomnias Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fugou County Minzhong Hospital

Zhoukou, Henan, 461300, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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).

Tuina Massage

Procedure

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

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction (EF)

    Time frame: 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%.

  2. Change in Pittsburgh Sleep Quality Index (PSQI) Score

    Time frame: Baseline and 3 months post-treatment

    To assess sleep quality. The total score ranges from 0-21, with higher scores indicating poorer sleep quality.

  3. Change in Apnea-Hypopnea Index (AHI)

    Time frame: Baseline and 3 months post-treatment

    Measured by overnight polysomnography, defined as the total number of apneas and hypopneas per hour of sleep.

  4. Change in Arterial Oxygen Saturation (SaO2)

    Time frame: Baseline and 3 months post-treatment

    Measured via arterial blood gas analysis to assess improvement in hypoxemia.

Secondary outcomes

  1. Change in End-Diastolic Volume (EDV)

    Time frame: Baseline and 3 months post-treatment

    Measured by echocardiography.

  2. Change in End-Systolic Volume (ESV)

    Time frame: Baseline and 3 months post-treatment

    Measured by echocardiography.

  3. Change in Epworth Sleepiness Scale (ESS) Score

    Time frame: Baseline and 3 months post-treatment

    To assess daytime sleepiness. The total score ranges from 0-24, with higher scores indicating greater sleepiness.

  4. Change in Lowest Oxygen Saturation (LSaO2)

    Time frame: Baseline and 3 months post-treatment

    Measured by polysomnography.

  5. Change in Longest Apnea Time (LAT)

    Time frame: Baseline and 3 months post-treatment

    Measured by polysomnography.

  6. Change in Arterial Partial Pressure of Oxygen (PaO2)

    Time frame: Baseline and 3 months post-treatment

    Measured via arterial blood gas analysis.

  7. Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2)

    Time frame: Baseline and 3 months post-treatment

    Measured via arterial blood gas analysis.

  8. Incidence of Adverse Reactions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weihua Peng

Other

Registry information

Official study title

The Impact of Continuous Positive Airway Pressure Combined With Physiotherapy on Ejection Fraction by Ameliorating Sleep Disturbance and Hypoxemia in Elderly Patients With Chronic Heart Failure and Obstructive Sleep Apnea: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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