Evaluation of Left Ventricular Function and Therapeutic Effect of CPAP in Patients With OSAS by 3D STE

NCT ID: NCT04957004

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-22
• Study Completion Date: 2020-06-30

Brief Summary

The changes of left ventricular function in patients with sleep apnea were studied by three-dimensional speckle-tracking echocardiography to evaluate the changes of left ventricular function after CPAP treatment

Detailed Description

Research purposes: (1) Use 3D speckle tracking echocardiography to measure the diastolic and systolic strains of the left atrium and left ventricle of OSAS patients, in order to evaluate the impact and degree of OSA on left ventricular function.

(2) By comparing the changes in the three-dimensional ultrasound strain index of the left ventricle of patients before and after CPAP treatment, and in patients receiving and not receiving CPAP treatment, to evaluate whether CPAP treatment contributes to the improvement of cardiac function in patients with OSAS, and to infer the best suitable intervention population and using time, providing reference basis for clinical treatment.

(3) Discovery of serological indicators that predict the severity of the disease and predict the impairment of heart function Study design: This study is a prospective, observational controlled study. It is planned to include 30 cases of newly diagnosed OSAS patients in the Peking University Third Hospital and a control group selected according to age and gender matching. The three-dimensional strain of the left atrium and left ventricle of the crowd is measured by the 3D speckle tracking technology, and the serological indicators are detected. The OSAS group and the control group were followed up during the course of receiving or not receiving CPAP.

Conditions

OSA; Left Ventricular Dysfunction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

OSA patients

Patients with OSA who have not been treated with CPAP

CPAP

Intervention Type: DEVICE

CPAP ventilator was worn at nigh

control group

health control except OSA by using sleep monitorin

No interventions assigned to this group

Interventions

CPAP

CPAP ventilator was worn at nigh

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. OSA met the diagnostic criteria of obstructive sleep apnea in the United States Classification of Sleep Diseases in 2014

2. Between the ages of 18 and 80, regardless of gender

3. Sign informed consent

Exclusion Criteria

1. previously diagnosed patients with heart failure,

2. coronary artery disease,

3. valvular disease,

4. cardiomyopathy,

5. arrhythmia,

6. chronic obstructive/ restrictive pulmonary disease,

7. thyroid dysfunction (including hypothyroidism or hyperthyroidism),

8. already treated with CPAP,

9. poor image quality of echocardiography.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongzhen Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

M2017397

Identifier Type: -

Identifier Source: org_study_id