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

January 18, 2026 updated by: Xiaosong Dong, Peking University People's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
344

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Suspected OSA and recommended to sleep center for HSAT monitoring;
  2. Voluntary and signed informed consent;
  3. Access to the Internet, email and phone calls;
  4. 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);
  5. 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Telemedicine treatment group
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
Automatic continuous positive airway pressure (APAP) is the routine and first line treatment for patients with sleep apnea
Other: Outpatient treatment group
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
Automatic continuous positive airway pressure (APAP) is the routine and first line treatment for patients with sleep apnea

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24-hour ambulatory blood pressure
Time Frame: 12weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The compliance of APAP treatment
Time Frame: 12weeks
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
Sleepiness symptom
Time Frame: 12weeks
Daytime sleepiness was measured by the Epworth Sleepiness Scale (ESS, score range 0-24), with higher scores indicating greater sleepiness
12weeks
Sleep Functional Outcome
Time Frame: 12weeks
Disease-specific functional status was assessed using the 10-item Functional Outcomes of Sleep Questionnaire (FOSQ-10), a validated instrument designed to quantify the impact of sleepiness on daytime functioning. The FOSQ-10 comprises 10 items, yielding a total score ranging from 5 to 20, with higher scores indicating better daytime functional status and less impairment in daily activities.
12weeks
OSA-specific quality of life
Time Frame: 12 weeks
OSA-specific quality of life was evaluated with the 32-item Quebec Sleep Questionnaire (QSQ), which measures five domains (daytime sleepiness, diurnal symptoms, nocturnal symptoms, emotions, and social interactions) on a 7-point Likert scale, with higher scores indicating better quality of life.
12 weeks
Sleep quality
Time Frame: 12 weeks
General sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
12 weeks
Mood and depressive symptoms
Time Frame: 12 weeks
Mood and depressive symptoms were assessed using the 10-item Center for Epidemiologic Studies Depression Scale (CES-D-10), a self-report questionnaire evaluating the frequency of depressive symptoms over the past week. Each item is rated on a 4-point scale (0-3), yielding a total score of 0-30, with higher scores indicating greater depressive symptom burden.
12 weeks
Insomnia symptoms
Time Frame: 12 weeks
Insomnia symptoms were assessed using the Insomnia Severity Index (ISI). The total ISI score ranges from 0 to 28, with higher scores indicating more severe insomnia.
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Liver enzyme
Time Frame: 12 weeks
Serum liver enzyme levels including alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will be measured as indicators of hepatic function. These enzymes are routinely quantified in fasting blood samples using standardized biochemical assays. ALT and AST elevations reflect hepatocellular injury, inflammation, or metabolic stress. Tests will be performed by the hospital's central biochemical laboratory. ALT and AST values will be reported in international units per liter (U/L)
12 weeks
Lipid profile
Time Frame: 12 weeks
The lipid profile includes measurements of fasting total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). These markers are measured in the hospital's biochemical laboratory and are established indicators of lipid metabolism and cardiovascular risk. Results will be expressed in mmol/L according to laboratory standards.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaosong Dong, Sleep Medicine Center, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022PHB359-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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