Comprehensive Care of Sleep Disordered Breathing

NCT ID: NCT07339371

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

11100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2029-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Disordered Breathing (SDB)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Clinical Management for SDB

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Peking University Hospital of Stomatology

OTHER

Sponsor Role collaborator

Shantou University Medical College

OTHER

Sponsor Role collaborator

Shanghai Institute of Hypertension

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Jishuitan Hospital

OTHER

Sponsor Role collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shao-Ping Nie

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Shao-Ping Nie, MD, PhD

Role: CONTACT

86-10-84005256

Facility Contacts

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Shao-Ping Nie, MD, PhD

Role: primary

Other Identifiers

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KS2025041

Identifier Type: -

Identifier Source: org_study_id

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