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A Cohort Study on Increasing Blood Pressure Benefits in Sleep Apnea Patients After CPAP Treatment
Led by Beijing Anzhen Hospital · Updated on 2026-01-21
200
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating how Continuous Positive Airway Pressure CPAP treatment affects blood pressure in adults aged 18 to 70 who have obstructive sleep apnea OSA and high or uncontrolled blood pressure. The study aims to find out which patients benefit the most in blood pressure reduction from CPAP and whether adding a sleep aid medication can improve CPAP effectiveness for those who experience insomnia or frequent awakenings at night. This observational study is sponsored by Beijing Anzhen Hospital and focuses on blood pressure control and sleep quality in OSA patients. Participants will use an auto-titrating CPAP device for at least 4 hours each night and at least 21 nights per month over about 3 months, with fitted masks and support to encourage use. Those with difficulty sleeping may also choose to take a short course of sleep aid medication trazodone or zopiclone for 4 weeks. The study forms natural sub-groups based on these interventions CPAP only, CPAP plus trazodone, CPAP plus zopiclone, or drug only for those who decline CPAP. During the study, participants will undergo full-night sleep monitoring and 24-hour blood pressure monitoring to tailor CPAP pressure. Researchers will use questionnaires, actigraphy wristwatches, and additional sleep studies to observe changes in sleep and blood pressure. Blood and urine samples will be collected for safety checks. Participants are free to withdraw anytime without penalty, and study-related care including devices, medications, and tests are provided at no cost. The primary outcome measured is blood pressure after 3 months of CPAP treatment.
CONDITIONS
Brief Title
A Cohort Study on Increasing Blood Pressure Benefits in Sleep Apnea Patients After CPAP Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Diagnosed with obstructive sleep apnea by overnight polysomnography with either AHI 65 plus symptoms or AHI 615 per hour
- Have office blood pressure between 120-159/80-99 mmHg or are on stable blood pressure medication but not at target
- Able to tolerate 24-hour ambulatory and continuous blood pressure monitoring
You will not qualify if you...
- Previously diagnosed with obstructive sleep apnea and currently receiving treatment such as CPAP or surgery
- Having secondary hypertension from other causes like kidney disease or Cushing's syndrome
- Unstable health conditions including recent cardiovascular events, severe sleepiness, cognitive impairment, active mental illness, or substance abuse
- Rheumatic immune diseases or malignant tumors
- Large artery diseases such as arterial dissection or aneurysm
- Conditions preventing accurate blood pressure measurement like atrial fibrillation
- Early-onset familial hypertension
- Use of sleep aid medications within 4 weeks before enrollment
- Allergy or contraindication to study drugs (trazodone, zopiclone)
- Pregnant, breastfeeding, or planning pregnancy
- Working night shifts 3 or more nights per week or diagnosed circadian rhythm disorder
- Participating in other interventional clinical trials
Research Team
J
Jiang Xie, M.D.
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