Comprehensive Care of Sleep Disordered Breathing
ConditionSleep Disordered Breathing (SDB)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years.
Patients who have completed sleep breathing monitoring within 1 month prior to enrollment.
Capable of providing signed informed consent.
Disqualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical Management for SDB
Other interventionParticipants 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.
Treatment groups
11,100 Participants
are divided into 1 treatment groupGroup A: SDB Comprehensive Management Cohort1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality
Time frame
3 and 12 months after enrollment, then annually thereafter, with a maximum follow-up duration of 5 yearsSecondary outcomes
1
All-cause hospitalization
Time frame
Up to 5 years.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Anzhen Hospital
Lead sponsor
Beijing Hospital
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Peking University Hospital of Stomatology
Collaborator
Shantou University Medical College
Collaborator
Shanghai Institute of Hypertension
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Beijing Tiantan Hospital
Collaborator
Beijing Jishuitan Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
West China Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
Source ClinicalTrials.gov
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