Comprehensive Care of Sleep Disordered Breathing (Care-SDB)

A Prospective Cohort Study on Comprehensive Care of Sleep Disordered Breathing (Care-SDB Study)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disordered Breathing (SDB)
• Intervention / Treatment: Other: Clinical Management for SDB

• Study Type: Observational
• Enrollment (Estimated): 11100

Contacts and Locations

• Study Contact: Name: Shao-Ping Nie, MD, PhD; Phone Number: 86-10-84005256; Email: spnie@ccmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Beijing Anzhen Hospital, Capital Medical University
      • Contact: Shao-Ping Nie, MD, PhD; Email: spnie@ccmu.edu.cn
      • Principal Investigator: Shao-Ping Nie, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SDB Comprehensive Management Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause hospitalization		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.	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.	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.	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.	Baseline and up to 5 years.

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Beijing Friendship Hospital; Beijing Tiantan Hospital; West China Hospital; First Affiliated Hospital of Fujian Medical University; Beijing Chao Yang Hospital; Beijing Hospital; Peking University Hospital of Stomatology; Second Xiangya Hospital of Central South University; Beijing Jishuitan Hospital; Shantou University Medical College; Shanghai Institute of Hypertension

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Sleep Disordered Breathing; Comprehensive Care
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes
• Other Study ID Numbers: KS2025041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No