Sleep Disordered Breathing (SDB)
Conditions
Keywords
Comprehensive Care, Sleep Disordered Breathing
Brief summary
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.
Interventions
OTHERClinical 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.
Sponsors
Beijing Anzhen Hospital
Beijing Hospital
Second Xiangya Hospital of Central South University
Peking University Hospital of Stomatology
Shantou University Medical College
Shanghai Institute of Hypertension
First Affiliated Hospital of Fujian Medical University
Beijing Tiantan Hospital
Beijing Jishuitan Hospital
Beijing Friendship Hospital
West China Hospital
Beijing Chao Yang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | 3 and 12 months after enrollment, then annually thereafter, with a maximum follow-up duration of 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause hospitalization | Up to 5 years. | — |
| Comorbidity-related Adverse Events | Up to 5 years. | 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. |
| Change from Baseline in Sleep-Disordered Breathing Parameters | Baseline and up to 5 years. | Evaluation of changes in parameters such as Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) through repeated sleep breathing monitoring. |
| Change in Daytime Sleepiness assessed by Epworth Sleepiness Scale (ESS) | Baseline and up to 5 years. | 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. |
| Quality of Life assessed by 36-Item Short Form Survey (SF-36) | Baseline and up to 5 years. | 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. |
Countries
China
Contacts
CONTACTShao-Ping Nie, MD, PhD
Outcome results
None listed