Sleep Disordered Breathing (SDB)NCT06755840
Sleep Disordered Breathing and Multimorbidity: The Xiangya SDB Cohort Study
An observational study of Sleep Disordered Breathing (SDB) and Sleep Apnea, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Sleep disordered breathing (SDB) is one of the most common sleep disorders, including obstructive sleep apnea (OSA), central sleep apnea (CSA), sleep-related hypoventilation, hypoxemia, etc., with OSA being the most prevalent. Also, SDB shows high comorbidities with multisystem diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Disordered Breathing (SDB), Sleep Apnea, Cardiometabolic Diseases
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2025to 31 Oct 2035
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: participants who complete at least one overnight sleep monitor session in the Sleep Medicine Center of Xiangya hospital Central South University
Who may be able to join
- 1) Participants who were suspected of sleep disordered breathing must complete at least one overnight sleep monitoring at the Sleep Medicine Center at Xiangya Hospital.
- 2) Participants can finish any assessment for each comorbid system by questionnaires, scales, physical examinations and tests, etc. independently or with the assistance.
- 3) Participants agreed to participate in this study with signing an informed consent form.
Who cannot join
- Participants who refused to participate in this study or whose clinical data was lost.
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, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha
Yuan Zhang, 86-0731-84327029, zhangyuan9194@csu.edu.cn
About this study
Sleep disordered breathing (SDB) is one of the most common sleep disorders, including obstructive sleep apnea (OSA), central sleep apnea (CSA), sleep-related hypoventilation, hypoxemia, etc., with OSA being the most prevalent. Also, SDB shows high comorbidities with multisystem diseases. Furthermore, compared to patients with pure SDB, those comorbid with SDB and other disorders like cardiometabolic dysfunction and cognitive impairment experience poorer quality of life, higher rate of disease progression and mortality, and a greater economic burden. Currently, there are limited cohorts to study the associations between SDB and multisystem diseases. The aim of this study is to establish an ambispective clinical cohort for SDB in Xiangya hospital from central-south China (Xiangya Sleep Disordered Breathing Cohort, Xiangya SDB cohort) including retrospective part and prospective part, which covers multi-dimensional data of sleep monitoring, demographic, daily behaviors, clinical manifestations and comorbidities status, life quality, treatment information and evaluation, etc. by self-reported questionnaires and objective assessments and tests. Besides, whole peripheral blood is drawn for following biomarkers study and omics analysis. The main goal is to achieve precise management of SDB and related multimorbidity, containing to early identify risk individuals for multisystem impairment, significantly improve their prognosis and ultimately enhance overall health. In detail: first, to reveal how multisystem impairment related to SDB evolves; second, to identify which indicators closely involve system dysfunction due to SDB; third, to build an efficient model and a cost-effective platform to screen high-risk population and tract therapeutic effect.
Read the detailed description
This study will be designed as a non-interventional and ambispective cohort study incorporating a retrospective part (Xiangya SDB cohort-Retrospective part) and a prospective part (Xiangya SDB cohort-Prospective part). It has received approval from the Medical Ethics Committee of Xiangya Hospital Central South University on August 21, 2024. The study will collect basic information, sleep parameters, clinical manifestation, comorbidities status, life quality and mortality from participants, through subjective and objective questionnaires, physical examinations, sleep monitoring, laboratory tests (blood routine test, serum biochemistry, myocardial enzymes, etc.), imaging tests (CT, echocardiogram, etc.) and other specific tests (pulmonary function test, etc.), as well as subsequent annual visits.
Xiangya SDB cohort-Retrospective part: The participants in this part primarily include individuals who completed sleep monitoring at the Sleep Medicine Center of Xiangya Hospital of Central South University from January 1, 2016 to January 14, 2025. Relevant comorbidities diagnoses and treatment data will be extracted from electronic health records. Meanwhile, questionnaires, physical examinations, laboratory tests, imaging tests, echocardiograms and pulmonary function tests, etc. will also be accessed to evaluate multisystem function and impairments. Subsequent long-term visits will collect all-cause and specific-cause death and evaluate the improvement and/or progression of cardiovascular, metabolic, respiratory, nervous, mental and neoplastic disorders, with supplementary data gathered from historical records.
Xiangya SDB cohort-Prospective part: The prospective cohort will begin enrolling participants from January 15, 2025, with their first sleep monitoring and the date of enrollment as the baseline visit. Concurrently, their basic information, clinical data, questionnaires related to sleep habits and quality, comorbidities status, physical examination, hospital laboratory and imaging data and pulmonary function test, etc. will also be collected. Subsequently, participants will be followed up every 12 to 24 months through phone calls, home visits or hospital visits.
Notably, participants signing informed consent will have an additional 10 ml of peripheral blood collected during routine clinical care (outpatient visits, hospitalizations, follow-ups, etc.) for biomarkers and multi-omics research. The follow-up visits will include: 1) death event and the causes; 2) relevant questionnaires and tests described as above to assess the function and diseases disease status of each comorbid system.
- Conditions
- Sleep Disordered Breathing (SDB), Sleep Apnea, Cardiometabolic Diseases, Multimorbidity, Neurodegenerative Diseases
- Keywords
- sleep disordered breathing, obstructive sleep apnea, central sleep apnea, cardiovascular diseases, metabolic diseases, respiratory diseases, nervous system diseases, mental disorders, neoplasms, multimorbidity
- Medical subject headings
- Sleep Apnea Syndromes, Neurodegenerative Diseases, Sleep Apnea, Obstructive, Sleep Apnea, Central, Cardiovascular Diseases, Metabolic Diseases, Respiratory Tract Diseases, Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Death event
Death due to any cause or specific cause
Measured: From participants agreed to participate in this study until the date of death from any or specific cause or the end of the study, whichever came first, assessed up to 10 years.
Secondary outcomes (11)
Life quality as measured by the 12-item short form health survey (SF-12)
The seven situations of SF-12 include physical function, role limitations due to physical health or emotional problems, bodily pain, general health perceptions, vitality, and social function. The scoring criteria for the SF-12 scale is based on a percentage system, where higher scores indicate better quality of life.
Measured: Through study completion, an average of 2 years
Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS)
ESS is intended to assess sleepiness liability (from 0 to 3 score) across eight different situations, the higher score indicates more likely to sleepiness.
Measured: Through study completion, an average of 2 years
Sleep quality and behavior as measured by the Pittsburgh Sleep Quality Index (PSQI)
The seven different dimensions of PSQI include sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total score of PSQI ranges from 0 to 21 and the higher score indicates poorer sleep.
Measured: Through study completion, an average of 2 years
Rapid Eye Movement Sleep Behavior Disorder Questionnaire Hong Kong (RBD-HK) applied for RBD screening
RBD-HK mainly accesses symptoms and severity of RBD.
Measured: Through study completion, an average of 2 years
Cognitive function and impairment as measured by Ascertain Dementia 8 (AD8)
AD8 is intended to access cognitive function and impairment through eight concise questions. A score of 2 or above indicates cognitive impairment.
Measured: Through study completion, an average of 2 years
Number of participants with cardiometabolic diseases or events
The occurrence of cardiometabolic diseases or events (e.g. hypertension, heart failure, ACS and DM, etc.) are identified by self-report or their electronic health records and tests (e.g. blood pressure, blood glucose, lipids and hormone levels, echocardiogram, ECG etc.)
Measured: Through study completion, an average of 2 years
Number of participants with respiratory diseases or events
The occurrence of respiratory diseases or events (e.g. COPD and asthma, or hospitalization due to exacerbation, etc.) are identified by self-report or their electronic health records and tests (e.g. lung function test parameters, etc.)
Measured: Through study completion, an average of 2 years
Number of participants with nervous system and mental diseases and status
The occurrence of nervous system and mental diseases and status (e.g. stroke, dementia, Parkinson's disease, depression, etc.) are identified by participants self-report or their electronic health records.
Measured: Through study completion, an average of 2 years
Number of participants with digestive system diseases or events
The occurrence of digestive diseases (e.g. GERD, crohn's disease, ulcerative colitis, etc.) are identified by participants self-report or their electronic health records
Measured: Through study completion, an average of 2 years
Number of participants with kidney diseases or events
The occurrence of kidney diseases or events (e.g. CKD etc.) are identified by self-report or their electronic health records and tests (e.g. eGFR etc.)
Measured: Through study completion, an average of 2 years
Number of participants with neoplasms diseases or events
The occurrence of neoplasms diseases or events (e.g. any type of tumor, adverse events, etc. ) are identified by self-report or their electronic health records
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start15 Jan 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Oct 2035 (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.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755840
- Sponsor's protocol ID
- 2024080978
- Status last verified
- Aug 2024
- First submitted
- 21 Nov 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing and Multimorbidity: The Xiangya SDB Cohort Study
- ClinicalTrials.gov ID
- NCT06755840
- Acronym / sponsor ID
- 2024080978
- Conditions
- Sleep Disordered Breathing (SDB), Sleep Apnea, Cardiometabolic Diseases, Multimorbidity, Neurodegenerative Diseases
- Keywords
- sleep disordered breathing, obstructive sleep apnea, central sleep apnea, cardiovascular diseases, metabolic diseases, respiratory diseases, nervous system diseases, mental disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Oct 2035 (estimated)
- First posted
- 1 Jan 2025 (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.
Sleep disordered breathing (SDB) is one of the most common sleep disorders, including obstructive sleep apnea (OSA), central sleep apnea (CSA), sleep-related hypoventilation, hypoxemia, etc., with OSA being the most prevalent. Also, SDB shows high comorbidities with multisystem diseases. Furthermore, compared to patients with pure SDB, those comorbid with SDB and other disorders like cardiometabolic dysfunction and cognitive impairment experience poorer quality of life, higher rate of disease progression and mortality, and a greater economic burden. Currently, there are limited cohorts to study the associations between SDB and multisystem diseases. The aim of this study is to establish an ambispective clinical cohort for SDB in Xiangya hospital from central-south China (Xiangya Sleep Disordered Breathing Cohort, Xiangya SDB cohort) including retrospective part and prospective part, which covers multi-dimensional data of sleep monitoring, demographic, daily behaviors, clinical manifestations and comorbidities status, life quality, treatment information and evaluation, etc. by self-reported questionnaires and objective assessments and tests. Besides, whole peripheral blood is drawn for following biomarkers study and omics analysis. The main goal is to achieve precise management of SDB and related multimorbidity, containing to early identify risk individuals for multisystem impairment, significantly improve their prognosis and ultimately enhance overall health. In detail: first, to reveal how multisystem impairment related to SDB evolves; second, to identify which indicators closely involve system dysfunction due to SDB; third, to build an efficient model and a cost-effective platform to screen high-risk population and tract therapeutic effect.
Detailed description
This study will be designed as a non-interventional and ambispective cohort study incorporating a retrospective part (Xiangya SDB cohort-Retrospective part) and a prospective part (Xiangya SDB cohort-Prospective part). It has received approval from the Medical Ethics Committee of Xiangya Hospital Central South University on August 21, 2024. The study will collect basic information, sleep parameters, clinical manifestation, comorbidities status, life quality and mortality from participants, through subjective and objective questionnaires, physical examinations, sleep monitoring, laboratory tests (blood routine test, serum biochemistry, myocardial enzymes, etc.), imaging tests (CT, echocardiogram, etc.) and other specific tests (pulmonary function test, etc.), as well as subsequent annual visits.
Xiangya SDB cohort-Retrospective part: The participants in this part primarily include individuals who completed sleep monitoring at the Sleep Medicine Center of Xiangya Hospital of Central South University from January 1, 2016 to January 14, 2025. Relevant comorbidities diagnoses and treatment data will be extracted from electronic health records. Meanwhile, questionnaires, physical examinations, laboratory tests, imaging tests, echocardiograms and pulmonary function tests, etc. will also be accessed to evaluate multisystem function and impairments. Subsequent long-term visits will collect all-cause and specific-cause death and evaluate the improvement and/or progression of cardiovascular, metabolic, respiratory, nervous, mental and neoplastic disorders, with supplementary data gathered from historical records.
Xiangya SDB cohort-Prospective part: The prospective cohort will begin enrolling participants from January 15, 2025, with their first sleep monitoring and the date of enrollment as the baseline visit. Concurrently, their basic information, clinical data, questionnaires related to sleep habits and quality, comorbidities status, physical examination, hospital laboratory and imaging data and pulmonary function test, etc. will also be collected. Subsequently, participants will be followed up every 12 to 24 months through phone calls, home visits or hospital visits.
Notably, participants signing informed consent will have an additional 10 ml of peripheral blood collected during routine clinical care (outpatient visits, hospitalizations, follow-ups, etc.) for biomarkers and multi-omics research. The follow-up visits will include: 1) death event and the causes; 2) relevant questionnaires and tests described as above to assess the function and diseases disease status of each comorbid system.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- participants who complete at least one overnight sleep monitor session in the Sleep Medicine Center of Xiangya hospital Central South University
Key inclusion criteria (3 listed)
- 1) Participants who were suspected of sleep disordered breathing must complete at least one overnight sleep monitoring at the Sleep Medicine Center at Xiangya Hospital.
- 2) Participants can finish any assessment for each comorbid system by questionnaires, scales, physical examinations and tests, etc. independently or with the assistance.
- 3) Participants agreed to participate in this study with signing an informed consent form.
Key exclusion criteria (1 listed)
- Participants who refused to participate in this study or whose clinical data was lost.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death event
Time frame: From participants agreed to participate in this study until the date of death from any or specific cause or the end of the study, whichever came first, assessed up to 10 years.
Death due to any cause or specific cause
11 secondary outcomes
Life quality as measured by the 12-item short form health survey (SF-12)
Time frame: Through study completion, an average of 2 years
Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS)
Time frame: Through study completion, an average of 2 years
Sleep quality and behavior as measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Through study completion, an average of 2 years
Rapid Eye Movement Sleep Behavior Disorder Questionnaire Hong Kong (RBD-HK) applied for RBD screening
Time frame: Through study completion, an average of 2 years
Cognitive function and impairment as measured by Ascertain Dementia 8 (AD8)
Time frame: Through study completion, an average of 2 years
Number of participants with cardiometabolic diseases or events
Time frame: Through study completion, an average of 2 years
Number of participants with respiratory diseases or events
Time frame: Through study completion, an average of 2 years
Number of participants with nervous system and mental diseases and status
Time frame: Through study completion, an average of 2 years
Number of participants with digestive system diseases or events
Time frame: Through study completion, an average of 2 years
Number of participants with kidney diseases or events
Time frame: Through study completion, an average of 2 years
Number of participants with neoplasms diseases or events
Time frame: Through study completion, an average of 2 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 3 Apr 2025.
- Individual participant dataSharing planned: No
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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) and Sleep Apnea, run by Xiangya Hospital of Central South University 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 1 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. 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 Yuan Zhang (86-0731-84327029, zhangyuan9194@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death event (time frame: From participants agreed to participate in this study until the date of death from any or specific cause or the end of the study, whichever came first, assessed up to 10 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 3 Apr 2025.