A Cohort Study on Increasing Blood Pressure Benefits in Sleep Apnea Patients After CPAP Treatment

NCT07357272 | Recruiting DMC

• 1 other identifier: KS2025179
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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 ≥ 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 ≥ 4 hours every night, for a total of ≥ 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.

Conditions

Sleep Apnea Syndrome, Obstructive; Hypertension (HTN)

Outcome Measures

Primary Outcomes (1)

• blood pressure

  The changes in blood pressure of the patient after receiving CPAP treatment

  After 3 months of CPAP treatment

Study Arms (1)

hypertension with OSA

We will enroll 200 adults 18-70 y with newly-diagnosed obstructive sleep apnea (AHI ≥5 + symptoms or ≥15/h) and untreated or sub-optimally controlled blood pressure (120-159/80-99 mmHg or on stable meds but not at target). All will undergo auto-titrating CPAP for 3 months (≥4 h/night, ≥21 nights/month) with mask-fitting, education and side-effect management to maximize adherence. Participants who report insomnia or frequent CPAP-related awakenings may additionally receive 4-week bedtime trazodone (25-150 mg) or zopiclone (3.75-7.5 mg) at physician discretion, creating natural sub-groups: CPAP-only, CPAP+trazodone, CPAP+zopiclone, or drug-only for those refusing CPAP. Outcomes: 24-h BP change, CPAP adherence, subjective/objective sleep quality. Exclusions: prior OSA therapy, secondary hypertension, unstable cardiopulmonary disease, pregnancy, rotating night shift, recent hypnotic use, or concurrent interventional trials.

Device: continuous positive airway pressure

Interventions

continuous positive airway pressure DEVICE

All will undergo auto-titrating CPAP for 3 months (≥4 h/night, ≥21 nights/month) with mask-fitting, education and side-effect management to maximize adherence.

hypertension with OSA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who meet the age and screening criteria

You may qualify if:

• Age between 18 and 70 years old;
• 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.
• 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;
• Able to tolerate 24-hour ambulatory blood pressure monitoring and continuous blood pressure monitoring;

You may not qualify if:

• Previously diagnosed with OSA and currently undergoing OSA treatment (such as CPAP, orthodontic devices, surgery, etc.);
• Secondary hypertension caused by other reasons other than OSA, such as renal artery stenosis, kidney disease, Cushing's syndrome, primary aldosteronism;
• 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);
• Rheumatic immune diseases and malignant tumors;
• Large artery diseases (such as giant cell arteritis, arterial dissection, aneurysm, etc.);
• Diseases that cannot accurately measure blood pressure (such as atrial fibrillation, upper limb vascular diseases);
• Early-onset familial hypertension;
• 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;
• Allergic or contraindicated to the potential study drugs (trazodone, zopiclone);
• Pregnant, lactating, or planning to become pregnant;
• Frequent night shift work (≥ 3 nights/week) or circadian rhythm disorder (diagnosed by a doctor);
• Participating in other interventional clinical trials.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

Related Publications (6)

• Meng Z, Chen Y, Yang T, Sun B, Luo C, Wei G, Xie X, Gu Y, Ding N, Zhang X, Xu J. New perspective on exploring the predictive factors of blood pressure reduction during CPAP treatment in people with severe OSA and hypertension: a prospective observational study. BMJ Open Respir Res. 2023 May;10(1):e001560. doi: 10.1136/bmjresp-2022-001560.

  PMID: 37169401 RESULT

• Pengo MF, Oscullo G, Gomez-Olivas JD, Bilo G, Parati G, Martinez-Garcia MA. Nocturnal BP Profile Predicts CPAP Effect on BP in Patients With OSA and Resistant Hypertension. Chest. 2023 Nov;164(5):1302-1304. doi: 10.1016/j.chest.2023.05.021. Epub 2023 Jun 17. No abstract available.

  PMID: 37364854 RESULT

• Sanchez-de-la-Torre M, Gracia-Lavedan E, Benitez ID, Zapater A, Torres G, Sanchez-de-la-Torre A, Aldoma A, de Batlle J, Targa A, Abad J, Duran-Cantolla J, Urrutia A, Mediano O, Masdeu MJ, Ordax-Carbajo E, Masa JF, De la Pena M, Mayos M, Coloma R, Montserrat JM, Chiner E, Minguez O, Pascual L, Cortijo A, Martinez D, Dalmases M, Lee CH, McEvoy RD, Barbe F; Spanish Sleep Network. Long-Term Effect of Obstructive Sleep Apnea and Continuous Positive Airway Pressure Treatment on Blood Pressure in Patients with Acute Coronary Syndrome: A Clinical Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1750-1759. doi: 10.1513/AnnalsATS.202203-260OC.

  PMID: 35442180 RESULT

• Labarca G, Schmidt A, Dreyse J, Jorquera J, Enos D, Torres G, Barbe F. Efficacy of continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA) and resistant hypertension (RH): Systematic review and meta-analysis. Sleep Med Rev. 2021 Aug;58:101446. doi: 10.1016/j.smrv.2021.101446. Epub 2021 Jan 28.

  PMID: 33607443 RESULT

• Wu H, Guo Y. Risk of resistant hypertension associated with insomnia in patients with obstructive sleep apnea. Sleep Med. 2023 Jan;101:445-451. doi: 10.1016/j.sleep.2022.12.001. Epub 2022 Dec 5.

  PMID: 36516601 RESULT

• Shiina K. Obstructive sleep apnea -related hypertension: a review of the literature and clinical management strategy. Hypertens Res. 2024 Nov;47(11):3085-3098. doi: 10.1038/s41440-024-01852-y. Epub 2024 Aug 29.

  PMID: 39210083 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, feces, saliva

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Jiang Xie, M.D.

CONTACT

+86 010-64456527; Frank782008@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: January 21, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2025-09

Locations

CN (1)