An observational study in Sleep Disordered Breathing (SDB), sponsored by Beijing Anzhen Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Beijing Anzhen Hospital · Observational
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's planned enrollment of 11,100 is above the median of 109 across 654 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Beijing Anzhen Hospital is the lead sponsor of 188 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adult patients presenting to the outpatient or inpatient departments of participating clinical centers across China who have completed or are scheduled for sleep breathing monitoring for suspected or confirmed SDB.
Exclusion Criteria:
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.
Other: Clinical Management for SDB
Participants receive standard clinical care and management for sleep-disordered breathing according to established clinical guidelines. This may include, but is not limited to, CPAP therapy, lifestyle modifications, oral appliances, or other medical interventions as determined by the treating physician.
All-cause mortality
Time frame: 3 and 12 months after enrollment, then annually thereafter, with a maximum follow-up duration of 5 years
All-cause hospitalization
Time frame: Up to 5 years.
Comorbidity-related Adverse Events
Major adverse cardiovascular and cerebrovascular events (MACCE, a composite endpoint including cardiac mortality, non-fatal myocardial infarction, non-fatal stroke, ischemia-driven revascularization and readmission due to angina), the individual endpoints included in MACCE. Occurrence and recurrence of arrhythmias such as atrial fibrillation. Respiratory-related adverse events (chronic obstructive pulmonary disease exacerbation, asthma attacks, progression of interstitial lung disease, and pulmonary embolism, etc). Metabolism-related adverse events (diabetes, diabetic complications, non-alcoholic fatty liver disease, etc). Psychology-related adverse events (anxiety and depression, cognitive impairment, Alzheimer's disease, Parkinson's disease, epilepsy, etc). Chronic kidney disease-related adverse events (progression of renal function to end-stage renal disease, significant decline in estimated glomerular filtration rate, etc) Tumor occurrence and progression.
Time frame: Up to 5 years.
Change from Baseline in Sleep-Disordered Breathing Parameters
Evaluation of changes in parameters such as Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) through repeated sleep breathing monitoring.
Time frame: Baseline and up to 5 years.
Change in Daytime Sleepiness assessed by Epworth Sleepiness Scale (ESS)
The ESS is a self-administered questionnaire with 8 questions. Each item is scored from 0 to 3, with a total score range of 0 to 24. Higher scores indicate increased daytime sleepiness, representing a worse outcome.
Time frame: Baseline and up to 5 years.
Quality of Life assessed by 36-Item Short Form Survey (SF-36)
The SF-36 Scale consists of eight scaled scores. Each scale is directly transformed into a 0-100 scale. Possible scores range from 0 to 100, where higher scores represent better health status or less disability, indicating a better outcome.
Time frame: Baseline and up to 5 years.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Beijing Anzhen Hospital