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

NCT ID: NCT05735444

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 633 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

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.

Conditions

Hypertension; Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation group

Continuous positive airway pressure

Intervention Type: DEVICE

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.

Interventions

Continuous 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ji-Guang Wang

Director of the Shanghai Institute of Hypertension and the Department of Hypertension

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiguang Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiguang Wang, MD, PhD

Role: CONTACT

jiguangw@163.com

+86-21-64370045 ext. 610911

Jiguang Wang, MD, PhD

Role: CONTACT

iguang_wang_jgw@yahoo.com

+86-21-64370045 ext. 610911

Facility Contacts

Jiguang Wang, MD, PhD

Role: primary

jiguangw@163.com

+86-21-64370045 ext. 610911

Other Identifiers

OSA-HT

Identifier Type: -

Identifier Source: org_study_id