A Cohort Study on Increasing Blood Pressure Benefits in Sleep Apnea Patients After CPAP Treatment
Hypertension (HTN) Β· Sleep Apnea Syndrome, Obstructive
Research Title "Quadruple-Blind Randomized Controlled Trial of the Effect of CPAP on Blood Pressure in Patients with Sleep Apnea" Why are we conducting this study?
* Sleep apnea (OSA) is very common, affecting approximately one in every eight adults. It makes it more difficult to control blood pressure.
* Continuous Positive Airway Pressure (CPAP) is the preferred treatment, but the effect on blood pressure varies from person to person.
* We want to know: Which patients experience the greatest reduction in blood pressure with CPAP? Can adding a little sleep aid medication for those who have trouble sleeping or frequently wake up at night improve the effectiveness of CPAP and lead to better blood pressure control? Who will participate?
* 18-70 years old, diagnosed with obstructive sleep apnea, with snoring, gasping, or daytime sleepiness.
* High blood pressure or newly diagnosed with mild hypertension, or taking 1-2 blood pressure-lowering medications but not reaching the target.
* Able to wear the CPAP mask every night and willing to undergo 3-month follow-up.
* Pregnant women, those already using CPAP, those with a history of heart disease/stroke in the last 3 months, those working night shifts β₯ 3 nights/week, or those participating in other intervention trials are not eligible.
What will the study do? First, conduct a full-night sleep monitoring and 24-hour blood pressure monitoring to adjust the most suitable CPAP pressure for you.
Wear the CPAP mask for β₯ 4 hours every night, for a total of β₯ 21 days per month, for approximately 3 months.
If you often wake up at night or have insomnia, you can voluntarily join the "sleep aid medication" group: take trazodone (25-150 mg) or zolpidem (3.75-7.5 mg) before bedtime for 4 weeks.
During this period, we will use questionnaires, a small wristwatch (actigraphy), and additional sleep monitoring to observe changes in sleep and blood pressure; we will also draw a small amount of blood and collect urine for routine safety checks.
You can withdraw at any time without any penalty and it will not affect your regular medical treatment.
Possible benefits
* Free comprehensive assessment of sleep and blood pressure, one-on-one guidance from a doctor.
* May lead to a reduction in blood pressure and improvement in nighttime sleep quality.
* Help future patients like you receive better treatment. Possible discomfort or risks
* CPAP: mask pressure marks, dry mouth and nose, feeling of suffocation, bloating; most people's symptoms are relieved after adjusting the humidifier or mask.
* Sleep aid medication: next-day drowsiness, dry mouth, dizziness, nausea; rare cases may include persistent penile erection in men (immediate medical consultation required); the risk of dependency for zolpidem after continuous use for 4 weeks is very low, but it still requires monitoring by a doctor.
* Check: wearing a blood pressure cuff and sleep monitoring device may cause slight inconvenience during sleep.
* If there is any injury related to the study, Anzhen Hospital will provide necessary treatment and compensation in accordance with Chinese laws.
Privacy and Costs
* Sleep monitoring, dynamic blood pressure, medications, and tests required for the study are all free.
* Your name and medical record will only be viewed by researchers and the ethics committee. Personal identity will not be disclosed when the article is published. Contact person
* Research Question: Dr. Xie Jiang 010-64456528 (during working days) / 131-6198-5564 (at other times)
* Rights and Benefits: Beijing Anzhen Hospital Ethics Committee 010-64456214 Voluntary Decision Whether to participate or not is completely voluntary. You can withdraw at any time without any reason, and it will not affect the medical care you are entitled to.