Sleep Apnea, Obstructive
Conditions
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.
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.
Interventions
Automatic continuous positive airway pressure (APAP) is the routine and first line treatment for patients with sleep apnea
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour ambulatory blood pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The compliance of APAP treatment | 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. |
| Sleepiness symptom | 12weeks | Daytime sleepiness was measured by the Epworth Sleepiness Scale (ESS, score range 0-24), with higher scores indicating greater sleepiness |
| Sleep Functional Outcome | 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. |
| OSA-specific quality of life | 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. |
| Sleep quality | 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. |
| Mood and depressive symptoms | 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. |
| Insomnia symptoms | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXiaosong Dong
Sleep Medicine Center, Peking University People's Hospital
Outcome results
None listed