Sleep apnea study tests CPAP plus sleep meds for better blood pressure control
NCT ID NCT07357272
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether using a CPAP machine, sometimes with a mild sleep aid, can help lower blood pressure in people with both sleep apnea and high blood pressure. About 200 adults aged 18-70 will use CPAP every night for 3 months. Those with insomnia can also take trazodone or zolpidem for 4 weeks. The goal is to find out who benefits most and if adding a sleep aid improves results.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
People who meet the age and screening criteria
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anzhen Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100069, China
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