Intervention and Effect of Sleep Pattern on Cardio-cerebrovascular Disease

Sleep Education and Its Effects on Cardio-cerebrovascular Disease in Pudong Community Elderly Cohort

Because of the growing population of older people, cardio-cerebrovascular diseases has been the most important aging-related chronic disease, studying the pathogenesis and early warning mechanisms of cardio-cerebrovascular diseases in depth, exploring optimal strategies for early diagnosis and treatments of cardio-cerebrovascular diseases has becoming the urgent public health problem in China. Aging causes cellular changes that change the sleep status in older adults, leading to an increased risk of disease and death. Meanwhile, the rising prevalence of chronic diseases among older adults also increases the impact of sleep deprivation. Insufficient sleep has being a serious challenge to the health status of the elderly. However, there is no clinically significant treatment for sleep disorders caused by chronic diseases. Medication helps to sleep but will also lead to drug dependence and increasing the risk of recurrent sleep disorders, which is unfavorable for disease control.

Studies have shown that older adults who sleep 7-8 hours at night have better physical and mental health, cognition and quality of life. Shorter sleep durations (6 hours or less) and longer sleep durations (greater than 9 hours) had strong associations with adverse health outcomes such as cardiovascular, metabolic, immune, cognitive diseases, other psychiatric disorders, and mortality.

Therefore, on the basis of the established Pudong community cohort, the project applicant led the team to adopt an open-label, blind endpoint, and cluster-randomized two-phase trial method to randomly assign cohort members into intervention group and control group. According to the sleep health intervention plan formulated by the clinical team, family doctor provides health education materials according to the actual situation of the intervention group regularly. Family doctors in the control group used conventional management methods. The final assessment was that compared to control group, whether the intervention group improved members' sleep quality, reduced members' cardiovascular disease events, and individual cardiovascular disease morbidity and all-cause mortality during the study period.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Non-Communicable Chronic Diseases
• Intervention / Treatment: Behavioral: sleep education, behavioral education

• Study Type: Interventional
• Enrollment (Estimated): 12800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Cardiology, Ren Ji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men or women aged ≥ 60 years；
• Participate in the cohort of Shanghai Pudong community;
• There is a family doctor or regular family doctor in the neighborhood committee who is willing to participate in this project；
• Sign the informed consent;
• No immigrant intention in the next 3 years;
• Not pregnant or planning to become pregnant;
• No malignant tumor, life expectancy ≥ 3 years;
• Participating in the annual community-based elderly group examination project in the next three years

Exclusion Criteria:

• Those who are unwilling to participate in clinical research;
• Patients who participate in other clinical research;
• Patients with a history of severe mental illness or deafness;
• Patients who cannot complete follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sleep education group	Behavioral: sleep education, behavioral education; Provide health education materials which covering sleep education, behavioral education, chronic diseases such as cardiovascular diseases. Topics touch on such as why you need healthy sleep? What methods can be used to regulate insomnia, and how to regulate sleep breathing problems? How do the elderly maintain a good sleep? What are the risk factors for cardiovascular and cerebrovascular diseases? How to reduce the risk of developing sleep disorders or chronic diseases through changing everyday life?
No Intervention: routine management group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence and/or prevalence of cardiovascular diseases such as myocardial infarction, stroke, heart failure, and cardiovascular death	the incidence and/or prevalence of cardiovascular diseases such as myocardial infarction, stroke, heart failure, and cardiovascular death	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all cause death	all cause death	3 years

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Jun Pu, MD, PhD, Cardiology, Ren Ji Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: sleep intervention; sleep education; cardio-cerebrovascular diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Cardiovascular Diseases; Chronic Disease; Cerebrovascular Disorders; Noncommunicable Diseases
• Other Study ID Numbers: Sleep Education

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No