Comprehensive Care of Sleep Disordered Breathing (Care-SDB)

Capital Medical University

Status: Not yet enrolling

Conditions: Sleep Disordered Breathing (SDB)

Treatments: Other: Clinical Management for SDB

Study type: Observational

Funder types: Other

Identifiers

NCT07339371

KS2025041

Details and patient eligibility

About

The Comprehensive Care of Sleep Disordered Breathing study (Care-SDB) is a prospective, multi-center, registry-based cohort study designed to investigate the integrated management of sleep-disordered breathing (SDB). The investigators aim to establish a nationwide SDB cohort and biobank to identify prognostic biomarkers, explore pathogenic mechanisms, and evaluate optimal treatment models. A total of 11,100 adult patients with recent sleep monitoring will be enrolled and followed longitudinally for up to 5 years. Data collection, including clinical outcomes and major adverse events, will be managed via a unified Electronic Data Capture platform. The results from Care-SDB are expected to provide critical evidence-based guidance for the risk stratification, standardized intervention, and personalized management of patients with sleep-disordered breathing.

Enrollment: 11,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Patients who have completed sleep breathing monitoring within 1 month prior to enrollment.
• Capable of providing signed informed consent.

Exclusion criteria

• Estimated life expectancy of less than 3 months.
• Refusal to participate in the study.
• Inability to cooperate with baseline data collection or follow-up evaluations.

Trial design

11,100 participants in 1 patient group

SDB Comprehensive Management Cohort

Description:

This is a multi-center, prospective, observational registration cohort of 11,100 adult patients (age ≥ 18). All participants must have completed sleep breathing monitoring within one month prior to enrollment. The cohort aims to establish a clinical database and biobank to explore SDB-related biomarkers and pathogenesis. Participants receive comprehensive clinical management, including potential treatments for SDB, such as continuous positive airway pressure (CPAP), oral appliances, surgery, or lifestyle interventions. Data on clinical baselines, sleep monitoring, laboratory tests, and imaging will be collected. Follow-up will be conducted for up to 5 years (at baseline, 3 months, 1 year, and annually thereafter) to evaluate clinical outcomes, including all-cause mortality and cardiovascular events.

Treatment:

Other: Clinical Management for SDB