The Effect of Telemedicine-Based APAP Management on 24-Hour Ambulatory Blood Pressure in Patients With Obstructive Sleep Apnea

NCT06064630 | Completed

• 1 other identifier: 2022PHB359-001
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• 24-hour ambulatory blood pressure

  24-hour mean blood pressure(Primary), Daytime mean blood pressure, Nighttime mean blood pressure, 24-hour Systolic blood pressure (SBP), Daytime SBP, Nighttime SBP, 24-hour Diastolic blood pressure (DBP), Daytime DBP, Nighttime DBP.

  12weeks

Secondary Outcomes (7)

• The compliance of APAP treatment

  12weeks

• Sleepiness symptom

  12weeks

• Sleep Functional Outcome

  12weeks

• OSA-specific quality of life

  12 weeks

• Sleep quality

  12 weeks

Other Outcomes (2)

• Liver enzyme

  12 weeks

• Lipid profile

  12 weeks

Study Arms (2)

Telemedicine treatment group

OTHER

Telemedicine group need to complete sleep-related questionnaires online. Participants in the telemedicine group will learn Home sleep apnea testing(HSAT) online and then complete overnight monitoring at home. Patients diagnosed with OSA after HSAT monitoring will receive standardized APAP treatment. At 1 month of APAP treatment, participants in the telemedicine group will be followed up by phone/video to check their APAP treatment compliance. After 3 months of APAP treatment, the telemedicine group will be followed up by phone/video to check their APAP treatment compliance at 3 month, and they will finish 24-hour ambulatory blood pressure monitoring.

Device: Automatic continuous positive airway pressure

Outpatient treatment group

OTHER

Outpatient group need to complete sleep-related paper questionnaires at sleep center. The sleep technicians will explain to the patients how to use the Home sleep apnea testing (HSAT) and then they will complete overnight monitoring at home. Patients diagnosed with OSA after HSAT monitoring will receive standardized APAP treatment. At 1 month of APAP treatment, participants in the outpatient group will be followed up at sleep center to check their APAP treatment compliance. After 3 months of APAP treatment, the outpatient group will be followed up to check their APAP treatment compliance at 3 month, and they will finish 24-hour ambulatory blood pressure monitoring.

Device: Automatic continuous positive airway pressure

Interventions

Automatic continuous positive airway pressure DEVICE

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

Outpatient treatment group; Telemedicine treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Xiaosong Dong

  Sleep Medicine Center, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: October 3, 2023
• Study Start: November 1, 2023
• Primary Completion: November 16, 2024
• Study Completion: November 18, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)