NCT07339371

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,100

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Jan 2029

Study Start

First participant enrolled

January 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

January 5, 2026

Last Update Submit

January 19, 2026

Conditions

Sleep Disordered Breathing (SDB)

Keywords

Comprehensive CareSleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    3 and 12 months after enrollment, then annually thereafter, with a maximum follow-up duration of 5 years

Secondary Outcomes (5)

  • All-cause hospitalization

    Up to 5 years.

  • Comorbidity-related Adverse Events

    Up to 5 years.

  • Change from Baseline in Sleep-Disordered Breathing Parameters

    Baseline and up to 5 years.

  • Change in Daytime Sleepiness assessed by Epworth Sleepiness Scale (ESS)

    Baseline and up to 5 years.

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

    Baseline and up to 5 years.

Study Arms (1)

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

Interventions

Clinical Management for SDBOTHER

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.

SDB Comprehensive Management Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age ≥ 18 years.
  • Patients who have completed sleep breathing monitoring within 1 month prior to enrollment.
  • Capable of providing signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Shao-Ping Nie, MD, PhD

CONTACT

86-10-84005256spnie@ccmu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

CN(1)