Sleep Apnea, ObstructiveNCT06064630
The Effect of Telemedicine-Based APAP Management on 24-Hour Ambulatory Blood Pressure in Patients With Obstructive Sleep Apnea
A study testing Automatic continuous positive airway pressure in people with Sleep Apnea, Obstructive, run by Peking University People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Automatic continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 18 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Automatic continuous positive airway pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic continuous positive airway pressureDevice
Automatic continuous positive airway pressure (APAP) is the routine and first line treatment for patients with sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Automatic continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12weeks
Secondary outcomes (7)
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.
Measured: 12weeks
Sleepiness symptom
Daytime sleepiness was measured by the Epworth Sleepiness Scale (ESS, score range 0-24), with higher scores indicating greater sleepiness
Measured: 12weeks
Sleep Functional Outcome
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.
Measured: 12weeks
OSA-specific quality of life
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.
Measured: 12 weeks
Sleep quality
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.
Measured: 12 weeks
Mood and depressive symptoms
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.
Measured: 12 weeks
Insomnia symptoms
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Nov 2023
- Primary completion16 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaosong Dong, Peking University People's Hospital
- Investigators
- Xiaosong Dong, Principal investigator, Sleep Medicine Center, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064630
- Sponsor's protocol ID
- 2022PHB359-001
- Status last verified
- Jan 2026
- First submitted
- 22 Aug 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telemedicine-Based APAP Management on 24-Hour Ambulatory Blood Pressure in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06064630
- Acronym / sponsor ID
- 2022PHB359-001
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine treatment group | Other | Device: Automatic continuous positive airway pressureTelemedicine 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. |
| Outpatient treatment group | Other | Device: Automatic continuous positive airway pressureOutpatient 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic continuous positive airway pressureAutomatic continuous positive airway pressure (APAP) is the routine and first line treatment for patients with sleep apnea | Device | Outpatient treatment group, Telemedicine treatment group |
Primary outcome
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.
7 secondary outcomes
The compliance of APAP treatment
Time frame: 12weeks
Sleepiness symptom
Time frame: 12weeks
Sleep Functional Outcome
Time frame: 12weeks
OSA-specific quality of life
Time frame: 12 weeks
Sleep quality
Time frame: 12 weeks
Mood and depressive symptoms
Time frame: 12 weeks
Insomnia symptoms
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaosong Dong principal investigator
Sleep Medicine Center, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic continuous positive airway pressure in people with Sleep Apnea, Obstructive, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour ambulatory blood pressure (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.