Chronic Heart FailureNCT07061171
CPAP and Physiotherapy for Heart Failure and Sleep Apnea in the Elderly
A study testing Continuous Positive Airway Pressure, Herbal Decoction and Acupuncture in people with Chronic Heart Failure and Obstructive Sleep Apnea, run by Weihua Peng at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Heart Failure, Obstructive Sleep Apnea
- What is being tested?
- Continuous Positive Airway Pressure, Herbal Decoction and Acupuncture
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- Continuous Positive Airway Pressure, Herbal Decoction, Acupuncture, Tuina Massage
- Keywords
- Continuous Positive Airway Pressure, Physiotherapy, Elderly, Chronic Heart Failure, Obstructive Sleep Apnea, Sleep Disturbance
- Medical subject headings
- Sleep Apnea, Obstructive, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
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 DecoctionDrug
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.
AcupunctureProcedure or surgery
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 MassageProcedure or surgery
Includes massage techniques applied to the head and occipital region to relax muscles and improve local circulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months post-treatment
Change in Arterial Oxygen Saturation (SaO2)
Measured via arterial blood gas analysis to assess improvement in hypoxemia.
Measured: Baseline and 3 months post-treatment
Secondary outcomes (8)
Change in End-Diastolic Volume (EDV)
Measured by echocardiography.
Measured: Baseline and 3 months post-treatment
Change in End-Systolic Volume (ESV)
Measured by echocardiography.
Measured: Baseline and 3 months post-treatment
Change in Epworth Sleepiness Scale (ESS) Score
To assess daytime sleepiness. The total score ranges from 0-24, with higher scores indicating greater sleepiness.
Measured: Baseline and 3 months post-treatment
Change in Lowest Oxygen Saturation (LSaO2)
Measured by polysomnography.
Measured: Baseline and 3 months post-treatment
Change in Longest Apnea Time (LAT)
Measured by polysomnography.
Measured: Baseline and 3 months post-treatment
Change in Arterial Partial Pressure of Oxygen (PaO2)
Measured via arterial blood gas analysis.
Measured: Baseline and 3 months post-treatment
Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Measured via arterial blood gas analysis.
Measured: Baseline and 3 months post-treatment
Incidence of Adverse Reactions
Recording of all adverse events experienced during the treatment period, such as nasal itching, nasal dryness, dry eyes, or skin redness.
Measured: During the 3-month treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weihua Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weihua Peng, Fugou County Minzhong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061171
- Sponsor's protocol ID
- 2023-B058
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07061171
- Acronym / sponsor ID
- 2023-B058
- Conditions
- Chronic Heart Failure, Obstructive Sleep Apnea
- Keywords
- Continuous Positive Airway Pressure, Physiotherapy, Elderly, Chronic Heart Failure, Obstructive Sleep Apnea, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Weihua PengUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group: CPAP plus Physiotherapy | Experimental | Device: Continuous Positive Airway Pressure, Drug: Herbal Decoction, Procedure: Acupuncture, Procedure: Tuina MassageIn 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. |
| Control Group: CPAP Alone | Active comparator | Device: Continuous Positive Airway PressurePatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureUsing 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. | Device | Control Group: CPAP Alone, Study Group: CPAP plus Physiotherapy |
| Herbal DecoctionA 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. | Drug | Study Group: CPAP plus Physiotherapy |
| AcupunctureDaily 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). | Procedure or surgery | Study Group: CPAP plus Physiotherapy |
| Tuina MassageIncludes massage techniques applied to the head and occipital region to relax muscles and improve local circulation. | Procedure or surgery | Study Group: CPAP plus Physiotherapy |
Primary outcome
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%.
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.
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.
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.
8 secondary outcomes
Change in End-Diastolic Volume (EDV)
Time frame: Baseline and 3 months post-treatment
Change in End-Systolic Volume (ESV)
Time frame: Baseline and 3 months post-treatment
Change in Epworth Sleepiness Scale (ESS) Score
Time frame: Baseline and 3 months post-treatment
Change in Lowest Oxygen Saturation (LSaO2)
Time frame: Baseline and 3 months post-treatment
Change in Longest Apnea Time (LAT)
Time frame: Baseline and 3 months post-treatment
Change in Arterial Partial Pressure of Oxygen (PaO2)
Time frame: Baseline and 3 months post-treatment
Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2)
Time frame: Baseline and 3 months post-treatment
Incidence of Adverse Reactions
Time frame: During the 3-month treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure, Herbal Decoction and Acupuncture in people with Chronic Heart Failure and Obstructive Sleep Apnea, run by Weihua Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (EF) (time frame: Baseline and 3 months post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.