Sleep Disordered Breathing and Multimorbidity: The Xiangya SDB Cohort Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

participants who complete at least one overnight sleep monitor session in the Sleep Medicine Center of Xiangya hospital Central South University

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Death event

Death due to any cause or specific cause

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.

Secondary outcomes

1

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.

Time frame
Through study completion, an average of 2 years
2

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.

Time frame
Through study completion, an average of 2 years
3

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.

Time frame
Through study completion, an average of 2 years
4

Rapid Eye Movement Sleep Behavior Disorder Questionnaire Hong Kong (RBD-HK) applied for RBD screening

RBD-HK mainly accesses symptoms and severity of RBD.

Time frame
Through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

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