Clinical trial NCT06755840: Sleep Disordered Breathing and Multimorbidity: The Xiangya SDB Cohort Study
Official title: Sleep Disordered Breathing and Multimorbidity: The Xiangya SDB Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants who complete at least one overnight sleep monitor session in the Sleep Medicine Center of Xiangya hospital Central South University

Brief 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. 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.

Eligibility 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.

Primary outcomes:
measure: Death event
timeFrame: 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:
measure: Life quality as measured by the 12-item short form health survey (SF-12)
timeFrame: Through study completion, an average of 2 years
measure: Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS)
timeFrame: Through study completion, an average of 2 years
measure: Sleep quality and behavior as measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Through study completion, an average of 2 years
measure: Rapid Eye Movement Sleep Behavior Disorder Questionnaire Hong Kong (RBD-HK) applied for RBD screening
timeFrame: Through study completion, an average of 2 years
measure: Cognitive function and impairment as measured by Ascertain Dementia 8 (AD8)
timeFrame: Through study completion, an average of 2 years
measure: Number of participants with cardiometabolic diseases or events
timeFrame: Through study completion, an average of 2 years
measure: Number of participants with respiratory diseases or events
timeFrame: Through study completion, an average of 2 years
measure: Number of participants with nervous system and mental diseases and status
timeFrame: Through study completion, an average of 2 years
measure: Number of participants with digestive system diseases or events
timeFrame: Through study completion, an average of 2 years
measure: Number of participants with kidney diseases or events
timeFrame: Through study completion, an average of 2 years
measure: Number of participants with neoplasms diseases or events
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: ChangSha
country: China
facility: Xiangya Hospital of Central South University
Study officials:
References: