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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06064630
• Other study ID #: 2022PHB359-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: September 2023
• Source: Peking University People's Hospital
• Contact: Huijie Yi
• Phone: 01088324207
• Email: 2011110194[@]stu.pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Suspected OSA and recommended to sleep center for HSAT monitoring;

2. Voluntary and signed informed consent;

3. Voluntary and can complete 24-hour ambulatory blood pressure monitoring and blood sample collection at the first visit and at 3 months follow-up;

4. Access to the Internet, email and phone calls;

5. 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);

6. Fluent Chinese expression;

Exclusion Criteria:

1. Blood pressure cuff should not be used (e.g., circumference of upper arm > 55cm, history of breast cancer, structural lesions of upper limb);

2. Has been treated with a CPAP or oral appliance;

3. Cardiac insufficiency, NYHA classes III-IV;

4. Clear central sleep apnea (AHI=15 times/hour, central events > 50%);

5. Expected life span < 2 years;

6. Pregnant women;

7. History of kidney failure or kidney transplantation;

8. Attention deficit hyperactivity disorder, use of wakefulness drugs;

9. Less than 5 hours of sleep per night on weekdays combined with other sleep problems (e.g., shift work, night shift, circadian rhythm disturbance);

10. Oxygen is needed when awake or sleeping;

11. Unstable condition: unstable angina pectoris, uncontrolled hypertension, severe COPD, tumor progression, or unstable mental illness;

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

Device:
• Automatic continuous positive airway pressure
Automatic continuous positive airway pressure (APAP) is the routine and first line treatment for patients with sleep apnea

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour ambulatory blood pressure	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	12weeks
Secondary	The compliance of APAP treatment	Evaluate the use time of auto positive airway pressure therapy per night, including the proportion of the number of days with good compliance and the average daily use of the daily use of the APAP during treatment	12weeks
Secondary	Sleep apnea related dysfunction	Using Sleep Functional Outcome Questionnaires (FOSQ-10) and Quebec sleep questionnaire(QSQ) to evaluate the daytime and nighttime function of patients. the total score of FOSQ-10 is 20, and the higher the score, the better the daytime functional status of patients. The item scores of QSQ is 1-7 using Likert 7-point scoring method, the score of each dimension is equal to the sum of the scores of items in the dimension divided by the number of items in the dimension. The total score of QSQ is the sum of the mean scores of the five dimensions divided by 5. The higher the score, the better the quality of life.	12weeks
Secondary	Sleepiness symptom	Using Sleepiness-wakefulness inability and fatigue Test (SWIFT) and Epworth Sleepiness Scale to evaluate the wakefulness and fatigue in patients, SWIFT consists of 12-items and ESS consists of 8-items, the total scores of the SWIFT and ESS scales are 36 and 24, respectively, patients with drowsiness showed higher scores.	12weeks
Secondary	blood lipids and fasting blood glucose test	Cardiovascular risk markers, including blood lipids (triglyceride, cholesterol, low-density lipoprotein and high-density lipoprotein), fasting blood glucose, and catecholamines and their metabolites, are tested in the hospital's biochemical laboratory	12 weeks
Secondary	Cost-effectiveness analysis	The cost analysis was performed considering 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.; The cost analysis was performed considering 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. Costs were measured in Chinese Yuan (CNY). Effects were measured in quality-adjusted life years (QALYs), which were estimated from EuroQol Five Dimensions Questionnaires (EQ-5D) tariffs. Generalized linear regression was performed to compare the costs between participants randomized to in-person or telemedicine management.	12weeks