The Effect of Remote Diagnosis and Treatment on 24 Hour Ambulatory Blood Pressure Rhythm of OSA Patients

Sleep Apnea, Obstructive Clinical Trial

Official title: The Effect of Remote Diagnosis and Treatment on 24 Hour Ambulatory Blood Pressure Rhythm of OSA Patients: A Randomized Controlled Study

Status Not yet recruiting

Clinical Trial Summary

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 ambulatory blood pressure management in patients with hypertension under the new telemedicine mode and the traditional medical mode through a single-center randomized controlled trial, so as to optimize the diagnosis and treatment process of OSA patients with hypertension, establish a more convenient and efficient remote diagnosis and treatment mode with reliable clinical outcome, and provide a theoretical basis for subsequent multi-center research and promotion

Clinical Trial Description

Patients who came to the hospital for snoring were randomly divided into the telemedicine group and the outpatient group, and the ambulatory blood pressure values and rhythm changes of the two groups were extracted. The 24-hour ambulatory blood pressure improvement of OSA patients in the telemedicine group and the outpatient group after 3 months of APAP treatment were compared. Investigators will also compare the OSA-related health care costs (i.e., sleep studies, staff salaries), patient costs (travel expenses incurred by patients and lost productivity due to medical visits), and total costs that sum the two between the two groups of patients for health cost-effectiveness . At the same time, the differences in compliance between the telemedicine group and the outpatient group and the improvements of subjective symptoms estimated by questionnaires after APAP treatment were compared, and the changes in OSA related cardiovascular risk biomarkers and metabolomics assessments after 3 months of APAP treatment between the telemedicine group and the outpatient group were compared, so as to explore the mechanism of APAP treatment to improve the ambulate blood pressure rhythm of OSA patients. In addtion, the subtypes of OSA will be classified according to the characteristics of sleep symptoms and sleep monitoring variables, and the response of different subtypes of OSA to blood pressure improvement after APAP treatment will be evaluated in our study，so as to lay foundation for precise treatment of OSA. Investigators has begun to recruit patients for the pilot study on July 1, and is progressing smoothly. ;

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

• NCT number: NCT06064630
• Study type: Interventional
• Source: Peking University People's Hospital
• Contact: Huijie Yi
• Phone: 01088324207
• Email: 2011110194@stu.pku.edu.cn
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Completion date: August 15, 2024