Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06064630
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-03
First Post:
2023-08-22
Brief Title:
The Effect of Remote Diagnosis and Treatment on 24 Hour Ambulatory Blood Pressure Rhythm of OSA Patients
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
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
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 ie 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 studyso 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None