Boosting the blood pressure benefit of CPAP for people with obstructive sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort of adults aged 18–70 with diagnosed obstructive sleep apnea who have elevated or uncontrolled office blood pressure. Participants will receive CPAP and be followed with standard polysomnography-confirmed diagnosis and repeated office blood pressure measurements to track changes over time. The study will look for clinical and sleep-related characteristics that predict larger blood pressure reductions with CPAP. It will also compare outcomes in people who use an additional sleep-promoting medication for fragmented sleep versus those who do not to see if improved sleep continuity enhances the BP response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 and 70 years old;
2. Diagnosed with obstructive sleep apnea (OSA) through overnight polysomnography (PSG), as follows: (1) AHI ≥ 5 times/hour and one of the following conditions is met: (1) The patient complains of daytime sleepiness, lack of sleepiness during sleep, fatigue or insomnia; (2) Waking up due to breathlessness or wheezing; (3) The bed partner or other witnesses report that the patient has habitual snoring, breathing interruptions or both during sleep. Or (2) AHI ≥ 15 times/hour.
3. Satisfy any of the following blood pressure conditions: (1) Office blood pressure 120-139/80-89 mmHg, with ≤ 2 cardiovascular risk factors; (2) Newly diagnosed blood pressure 140-159/90-99 mmHg and without cardiovascular risk factors; (3) Currently taking stable types and doses of antihypertensive drugs, but the office blood pressure has not reached the normal blood pressure standard (120/80 mmHg) with a low-risk level of cardiovascular risk for patients with hypertension; (4) Any non-cardiovascular risk level high-risk patient who voluntarily requests three-month CPAP treatment and accepts follow-up;
4. Able to tolerate 24-hour ambulatory blood pressure monitoring and continuous blood pressure monitoring;

Exclusion Criteria:

1. Previously diagnosed with OSA and currently undergoing OSA treatment (such as CPAP, orthodontic devices, surgery, etc.);
2. Secondary hypertension caused by other reasons other than OSA, such as renal artery stenosis, kidney disease, Cushing's syndrome, primary aldosteronism;
3. Unstable condition (having experienced cardiovascular events or major surgeries in the past 3 months, severe sleepiness (ESS ≥ 16 points), or cognitive impairment that makes it impossible to cooperate, active mental illness or drug/alcohol abuse);
4. Rheumatic immune diseases and malignant tumors;
5. Large artery diseases (such as giant cell arteritis, arterial dissection, aneurysm, etc.);
6. Diseases that cannot accurately measure blood pressure (such as atrial fibrillation, upper limb vascular diseases);
7. Early-onset familial hypertension;
8. Any prescription or over-the-counter sleep aid (benzodiazepines, non-benzodiazepines, melatonin receptor agonists, trazodone, sedative antipsychotic/antidepressants containing sedative components, OTC containing sedative components) within 4 weeks before enrollment;
9. Allergic or contraindicated to the potential study drugs (trazodone, zopiclone);
10. Pregnant, lactating, or planning to become pregnant;
11. Frequent night shift work (≥ 3 nights/week) or circadian rhythm disorder (diagnosed by a doctor);
12. Participating in other interventional clinical trials.

Where it's running

• Anzhen Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jiang Xie, M.D.
• Email: Frank782008@aliyun.com
• Phone: +86 010-64456527

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.