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Sleep apnea study tests CPAP plus sleep meds for better blood pressure control

NCT ID NCT07357272

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Anzhen Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100069, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.