The Effect of Telemedicine-Based APAP Management on 24-Hour Ambulatory Blood Pressure in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- 24-hour ambulatory blood pressure
研究概览
简要总结
Epidemiological studies have shown that OSA is closely related to the occurrence and development of cardiovascular diseases, especially hypertension. At present, there are 66 million patients with moderate to severe OSA in China, and the current diagnosis and treatment of OSA is mainly completed in the sleep center of the hospital, which is time-consuming and laborious, resulting in the delayed diagnosis and treatment of a large number of patients, making about 80% of potential OSA patients have not been diagnosed and treated in time. With the development of the Internet technologies, telemedicine has been increasingly applied to the diagnosis, treatment and management of chronic diseases with its advantages of convenience, interactivity, efficiency, sharing, coherence and breaking through the limitations of time and space. Our center has initially built a remote diagnosis and treatment management model for OSA. Compared with the traditional medical model, the medical and health economic analysis shows that the OSA diagnosis and treatment model based on telemedicine is more cost-effective, but its clinical efficacy needs to be further verified. Hypertension is a common complication in OSA patients, and continuous positive airway pressure (PAP) has a significant hypertensive effect in the treatment of OSA. However, whether clinical management based on remote diagnosis and treatment mode can achieve the same therapeutic effect as traditional face-to-face diagnosis and treatment mode in improving ambulate blood pressure in OSA patients needs to be further clarified. This study will compare the improvement of 24 hour ambulatory blood pressure in patients under the Telemedicine-Based APAP Management and the traditional outpatient management through a single-center randomized controlled trial.
详细描述
Patients presenting with snoring were randomized to telemedicine-based or conventional outpatient management. We compared changes in 24-hour ambulatory blood pressure after 3 months of APAP therapy between groups. Secondary outcomes included treatment adherence, patient-reported symptoms and biological parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected OSA and recommended to sleep center for HSAT monitoring;
- •Voluntary and signed informed consent;
- •Access to the Internet, email and phone calls;
- •Lived in Beijing for the last three months (subjects randomly assigned to the outpatient treatment group were able to travel to and from the sleep center);
- •Fluent Chinese expression;
排除标准
- •Blood pressure cuff should not be used (e.g., circumference of upper arm > 55cm, history of breast cancer, structural lesions of upper limb);
- •Has been treated with a CPAP or oral appliance;
- •Cardiac insufficiency, NYHA classes III-IV;
- •Clear central sleep apnea (AHI≥15 times/hour, central events > 50%);
- •Expected life span < 2 years;
- •Pregnant women;
- •History of kidney failure or kidney transplantation;
- •Attention deficit hyperactivity disorder, use of wakefulness drugs;
- •Less than 5 hours of sleep per night on weekdays combined with other sleep problems (e.g., shift work, night shift, circadian rhythm disturbance);
- •Oxygen is needed when awake or sleeping;
- •Unstable condition: unstable angina pectoris, uncontrolled hypertension, severe COPD, tumor progression, or unstable mental illness;
结局指标
主要结局
24-hour ambulatory blood pressure
时间窗: 12weeks
24-hour mean blood pressure, 24-hour mean Systolic blood pressure (SBP), 24-hour mean Diastolic blood pressure (Diastolic blood pressure), DBP), Nighttime mean SBP, Nighttime mean DBP, Nighttime mean blood pressure, Daytime mean blood pressure, Daytime mean SBP, Daytime mean DBP, rhythm pattern analysis of blood pressure
次要结局
- The compliance of APAP treatment(12weeks)
- Sleep apnea related dysfunction(12weeks)
- Sleepiness symptom(12weeks)
- blood lipids and fasting blood glucose test(12 weeks)
- Cost-effectiveness analysis(12weeks)
研究者
Xiaosong Dong
Clinical Professor
Peking University People's Hospital