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NCT Number: NCT07339371

Comprehensive Care of Sleep Disordered Breathing

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.

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Key information

Conditions

Sleep Disordered Breathing (SDB) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location contact

Shao-Ping Nie, MD, PhD

CONTACT

[email protected]

Shao-Ping Nie, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Management for SDB

Other

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.

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 years

Secondary outcomes

  1. All-cause hospitalization

    Time frame: Up to 5 years.

  2. Comorbidity-related Adverse Events

    Time frame: 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.

  3. Change from Baseline in Sleep-Disordered Breathing Parameters

    Time frame: 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.

  4. Change in Daytime Sleepiness assessed by Epworth Sleepiness Scale (ESS)

    Time frame: 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.

  5. Quality of Life assessed by 36-Item Short Form Survey (SF-36)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shao-Ping Nie, MD, PhD

CONTACT

[email protected]

86-10-84005256

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Care-SDB

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 14, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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