S365: A Multicenter Longitudinal Cohort of Sleep Health

NCT06760000 | Active Not Recruiting DMC

• 1 other identifier: IRB00001052-23207
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to explore the long-term health outcomes of sleep disorders in adults aged 18 and older, as well as to identify associated biomarkers and risk factors. The main questions it aims to answer are:

• What are the long-term health risks associated with sleep disorders, such as cognitive decline, cardiovascular diseases, or metabolic conditions?
• Are there specific biomarkers or patterns that can predict the onset or progression of sleep disorders? Participants diagnosed with sleep disorders (e.g., insomnia, sleep apnea) or identified as healthy controls will undergo home-based sleep monitoring and complete clinical assessments at baseline and during follow-ups over a 3-year period. Biological samples, including blood and stool, will also be collected to analyze potential biomarkers. Data will be used to develop predictive models for sleep disorder risk and outcomes.

Conditions

Sleep Disorder; Sleep

Keywords

Sleep Disorder; Home Monitoring; Multicenter Longitudinal Cohort

Outcome Measures

Primary Outcomes (1)

• Incidence of Sleep Disorders and Related Diseases

  * Measure the occurrence of sleep disorders and related diseases, including cognitive decline, cardiovascular diseases, and metabolic conditions, over the follow-up period. * Data will be collected through clinical evaluations, sleep monitoring (e.g., polysomnography, wearable devices), and laboratory analyses (e.g., blood biomarkers). * Key metrics include the development or progression of these conditions, assessed through standardized diagnostic criteria.

  36 months (Baseline and follow-ups at 12, 24, and 36 months)

Interventions

Five seasons Sleep Tracking Mat DEVICE

Non-contact mat monitoring sleep data through pulse wave detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adults aged 18 years and older, recruited from two primary sources: clinical sleep centers and online advertisements. Participants will be divided into two groups: those diagnosed with sleep disorders, including insomnia, sleep apnea, and parasomnia, and healthy controls with no clinical symptoms. Individuals with sleep disorders will be identified through polysomnography or equivalent diagnostic methods, ensuring accurate categorization. Recruitment will target a diverse population to reflect a broad range of demographic and lifestyle factors, such as age, gender, and socio-economic background. The healthy control group will include individuals diagnosed as free from sleep-related conditions during clinical evaluations or through self-reported health statuses verified by researchers. Exclusion criteria include individuals with severe mental illnesses (e.g., bipolar disorder, schizophrenia), infectious diseases (e.g., tuberculosis, HIV/AIDS), pregnan

You may qualify if:

• Willing to voluntarily participate in the study and provide signed informed consent.
• Gender is not restricted, and baseline age is 18 years or older.
• Experiencing sleep disorders and capable of complying with the study procedures and tests.

You may not qualify if:

• Diagnosed with severe mental health conditions, such as bipolar disorder, schizophrenia, or claustrophobia.
• Suffering from infectious diseases, including tuberculosis, HIV/AIDS, or syphilis.
• Pregnant women.
• Experiencing acute inflammatory responses at the time of enrollment.
• Long-term use of corticosteroids or undergoing hormone replacement therapy.
• Determined by the researcher to be unsuitable for participation for any reason.
• Patients with specific diseases (e.g., cardiovascular conditions) may be excluded if the study focuses on related comorbidities.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Institute of Medical Technology, Peking University Health Science Center

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)