Sleep Disordered Breathing (SDB)Care-SDBNCT07339371
Comprehensive Care of Sleep Disordered Breathing
An observational study of Sleep Disordered Breathing (SDB), run by Beijing Anzhen Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disordered Breathing (SDB)
- What is being tested?
- Clinical Management for SDB
- Type of treatment
- Pill or oral medicine
- How many people
- 11,100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years.
- Patients who have completed sleep breathing monitoring within 1 month prior to enrollment.
- Capable of providing signed informed consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Shao-Ping Nie, MD, PhD, spnie@ccmu.edu.cn
Shao-Ping Nie, MD, PhD
About this study
Official title: 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.
- Conditions
- Sleep Disordered Breathing (SDB)
- Being tested
- Clinical Management for SDB
- Keywords
- Comprehensive Care, Sleep Disordered Breathing
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical Management for SDB |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 3 and 12 months after enrollment, then annually thereafter, with a maximum follow-up duration of 5 years
Secondary outcomes (5)
All-cause hospitalization
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered Breathing (SDB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Second Xiangya Hospital of Central South University, Peking University Hospital of Stomatology, Shantou University Medical College, Shanghai Institute of Hypertension, First Affiliated Hospital of Fujian Medical University, Beijing Tiantan Hospital, Beijing Jishuitan Hospital, Beijing Friendship Hospital, West China Hospital, Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339371
- Sponsor's protocol ID
- KS2025041
- Acronym
- Care-SDB
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Comprehensive Care of Sleep Disordered Breathing (Care-SDB Study)
- ClinicalTrials.gov ID
- NCT07339371
- Acronym / sponsor ID
- Care-SDB / KS2025041
- Conditions
- Sleep Disordered Breathing (SDB)
- Keywords
- Comprehensive Care, Sleep Disordered Breathing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 11,100 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Beijing Hospital, Second Xiangya Hospital of Central South University, Peking University Hospital of Stomatology, Shantou University Medical College, Shanghai Institute of Hypertension, First Affiliated Hospital of Fujian Medical University, Beijing Tiantan Hospital, Beijing Jishuitan Hospital, Beijing Friendship Hospital, West China Hospital, Beijing Chao Yang Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SDB Comprehensive Management Cohort | – | Other: Clinical Management for SDBThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Patients who have completed sleep breathing monitoring within 1 month prior to enrollment.
- Capable of providing signed informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Management for SDBParticipants 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. | Other | SDB Comprehensive Management Cohort |
Primary outcome
All-cause mortality
Time frame: 3 and 12 months after enrollment, then annually thereafter, with a maximum follow-up duration of 5 years
5 secondary outcomes
All-cause hospitalization
Time frame: Up to 5 years.
Comorbidity-related Adverse Events
Time frame: Up to 5 years.
Change from Baseline in Sleep-Disordered Breathing Parameters
Time frame: Baseline and up to 5 years.
Change in Daytime Sleepiness assessed by Epworth Sleepiness Scale (ESS)
Time frame: Baseline and up to 5 years.
Quality of Life assessed by 36-Item Short Form Survey (SF-36)
Time frame: Baseline and up to 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disordered Breathing (SDB), run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shao-Ping Nie, MD, PhD (86-10-84005256, spnie@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 3 and 12 months after enrollment, then annually thereafter, with a maximum follow-up duration of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.