Registry of Obstructive Sleep Apnea 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
Shanghai Jiao Tong University School of Medicine · NCT05735444
This study looks at how well people with high blood pressure and sleep apnea stick to using a CPAP machine and how it affects their health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 633 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05735444 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the adherence to continuous positive airway pressure (CPAP) therapy in patients with hypertension and obstructive sleep apnea syndrome (OSAS) across multiple centers in China. It will assess both short- and long-term adherence to CPAP and identify predictors that influence this adherence. Additionally, the study will explore the relationship between CPAP adherence and various health outcomes, including blood pressure control and the incidence of cardiovascular events. The research is observational and involves patients who have been diagnosed with hypertension and suspected OSAS.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with hypertension who have a STOP-Bang score of 3 or higher and are currently undergoing CPAP therapy.
Not a fit: Patients with severe hypertension, other significant respiratory diseases, or those intolerant to CPAP therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of CPAP adherence and its impact on hypertension management, potentially leading to better cardiovascular outcomes for patients.
How similar studies have performed: While there have been studies on CPAP adherence, this registry approach focusing on hypertensive patients with OSAS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Clinic systolic/diastolic blood pressure ≥180/110 mmHg; 2. Previous or current treatment for OSAS without CPAP; 3. Severe respiratory diseases such as chronic obstructive pulmonary disease, or contraindications to CPAP therapy, such as pneumothorax, pulmonary bulla and new-onset stroke； 4. Sleep disorders or insomnia; 5. Intolerance of CPAP therapy; 6. Patient with cognitive dysfunction who are unable to provide informed consent; 7. Other circumstances that patients are not appropriate for the study upon the investigator's judgment.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Jiguang Wang, MD, PhD — Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: Jiguang Wang, MD, PhD
- Email: jiguangw@163.com
- Phone: +86-21-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Obstructive Sleep Apnea, Obstructive sleep apnea syndrome, Continuous positive airway pressure, Registry