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

NCT05735444 | Recruiting DMC

• 1 other identifier: OSA-HT
• Study Type: observational
• Target: 633
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Obstructive Sleep Apnea

Keywords

Hypertension; Obstructive sleep apnea syndrome; Continuous positive airway pressure; Registry

Outcome Measures

Primary Outcomes (1)

• Change in mean 24-hour ambulatory blood pressure after 12-month CPAP treatment from baseline

  Units on a mm Hg

  12 months

Secondary Outcomes (7)

• Change in mean daytime ambulatory blood pressure after 12-month CPAP treatment from baseline

  12 months

• Change in mean nighttime ambulatory blood pressure after 12-month CPAP treatment from baseline

  12 months

• Change in mean clinic blood pressure after 12-month CPAP treatment from baseline

  12 months

• Change in mean home blood pressure after 12-month CPAP treatment from baseline

  12 months

• Change in brachial-ankle pulse wave velocity after 12-month CPAP treatment from baseline

  12 months

Study Arms (1)

Observation group

Device: Continuous positive airway pressure

Interventions

Continuous positive airway pressure 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.

Observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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 all the inclusion criterias but not any of the exclusion criterias.

You may qualify if:

• Agree to participate in the study and sign the informed consent;
• At least 18 years old;
• STOP-Bang questionnaire, score ≥3 points;
• Complete polysomnography in hospital;
• Currently on CPAP therapy.

You may not qualify if:

• Clinic systolic/diastolic blood pressure ≥180/110 mmHg;
• Previous or current treatment for OSAS without CPAP;
• Severe respiratory diseases such as chronic obstructive pulmonary disease, or contraindications to CPAP therapy, such as pneumothorax, pulmonary bulla and new-onset stroke；
• Sleep disorders or insomnia;
• Intolerance of CPAP therapy;
• Patient with cognitive dysfunction who are unable to provide informed consent;
• Other circumstances that patients are not appropriate for the study upon the investigator's judgment.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

We collect 20 ml of venous blood and 20 ml of urine at baseline and the end of follow-up, respectively.

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

Study Officials

• Jiguang Wang, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiguang Wang, MD, PhD

CONTACT

+86-21-64370045; jiguangw@163.com

Jiguang Wang, MD, PhD

CONTACT

+86-21-64370045; iguang_wang_jgw@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension and the Department of Hypertension

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 21, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)