Sleep Disordered Breathing and Multimorbidity: The Xiangya SDB Cohort Study

NCT06755840 | Recruiting

• 1 other identifier: 2024080978
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Death event

  Death due to any cause or specific cause

  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)

  Through study completion, an average of 2 years

• Daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS)

  Through study completion, an average of 2 years

• Sleep quality and behavior as measured by the Pittsburgh Sleep Quality Index (PSQI)

  Through study completion, an average of 2 years

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

  Through study completion, an average of 2 years

• Cognitive function and impairment as measured by Ascertain Dementia 8 (AD8)

  Through study completion, an average of 2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \) Participants who were suspected of sleep disordered breathing must complete at least one overnight sleep monitoring at the Sleep Medicine Center at Xiangya Hospital.
• \) Participants can finish any assessment for each comorbid system by questionnaires, scales, physical examinations and tests, etc. independently or with the assistance.
• \) Participants agreed to participate in this study with signing an informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Sleep Apnea Syndromes; Neurodegenerative Diseases; Sleep Apnea, Obstructive; Sleep Apnea, Central; Cardiovascular Diseases; Metabolic Diseases; Respiratory Tract Diseases; Nervous System Diseases; Mental Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Yuan Zhang

CONTACT

86-0731-84327029; zhangyuan9194@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: January 1, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): October 31, 2035
• Last Updated: April 3, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)