RecruitingNCT05735444

Prospective National Multi-center Registry of Obstructive Sleep Apnea Syndrome in Hypertensive Patients in China

Screening, Diagnosis and Treatment of Obstructive Sleep Apnea Syndrome in Hypertensive Patients in China: A Prospective National Multi-center Registry

Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

633 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

Hypertension Obstructive Sleep Apnea

Summary

Study name: Screening, Diagnosis and Treatment of Obstructive Sleep Apnea Syndrome in Hypertensive Patients in China: A Prospective National Multi-center Registry. Rationale: Obstructive sleep apnoea syndrome (OSAS) is a common secondary cause of hypertension and significantly correlated with the risk of cardiovascular and cerebrovascular diseases. However, continuous positive airway pressure (CPAP) only shows modest blood pressure lowering effect, although it is effective in the relieve of daytime sleepiness and other symptoms of OSAS. One of the possible reasons for the low antihypertensive efficacy might be the low adherence to CPAP therapy. Nonetheless, few studies systematically investigated CPAP adherence with regard to its prediction and clinical relevance for cardiovascular protection and prevention. Objective: 1) To evaluate short- and long-term CPAP adherence in patients with hypertension and obstructive sleep apnea syndrome; 2) To investigate the predictors of short- and long-term CPAP adherence; 3) To explore the correlation between the CPAP adherence and blood pressure, target organ damage and the incidence of cardiovascular and cerebrovascular events. Study design: Prospective, multi-center, observational study. Study population: Patients with hypertension who are suspected to have obstructive sleep apnea syndrome due to snoring, daytime sleepiness and other related symptoms are considered eligible and should meet the following criterias: 1) Agree to participate in the study and sign the informed consent; 2) At least 18 years old; 3) STOP-Bang questionnaire, score ≥3 points; 4) Complete polysomnography in hospital; 5) Currently on CPAP therapy. Follow up: 3, 6 and 12 months after registry. Sample size estimation: At least 633 patients. Timeline: Start of subjects' enrollment: Jan 2023; End of subjects' enrollment: December 2026; End of study: December 2026. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study collects data across multiple hospitals in China about patients with obstructive sleep apnoea (OSA) — a condition where breathing repeatedly stops and starts during sleep — who also have high blood pressure and are currently using CPAP therapy (a machine that keeps the airway open while sleeping). The goal is to understand the relationship between sleep apnoea and blood pressure control in a large real-world patient population. **You may be eligible if...** - You are 18 or older - You have been assessed as being at risk for sleep apnoea (STOP-Bang score ≥ 3) - You have completed an overnight sleep study (polysomnography) in hospital - You are currently using a CPAP machine for your sleep apnoea - You have high blood pressure **You may NOT be eligible if...** - Your blood pressure is dangerously high (above 180/110 mmHg) - You have previously used or are using a non-CPAP treatment for sleep apnoea - You have severe lung disease (such as COPD) or other contraindications to CPAP (such as a collapsed lung) - You have other sleep disorders or insomnia - You are intolerant of CPAP therapy - You have cognitive problems that prevent you from giving informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous positive airway pressure

Continuous positive airway pressure (CPAP) is one of the standard medical treatments for patients with OSAS. The mechanism of CPAP probably involves maintenance of a positive pharyngeal transmural pressure so that the intraluminal pressure exceeds the surrounding pressure. CPAP also increases end-expiratory lung volume, which stabilises the upper airway through caudal traction.