Sleep Disordered Breathing and Multimorbidity: The Xiangya SDB Cohort Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Participants who refused to participate in this study or whose clinical data was lost.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06755840
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Xiangya Hospital of Central South University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sleep Disordered Breathing (SDB), Sleep Apnea, Cardiometabolic Diseases, Multimorbidity, Neurodegenerative Diseases

Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Yuan Zhang

[email protected]

86-0731-84327029

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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