Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294964
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-06
First Post:
2024-02-19
Brief Title:
Intervention and Effect of Sleep Pattern on Cardio-cerebrovascular Disease
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Sleep Education and Its Effects on Cardio-cerebrovascular Disease in Pudong Community Elderly Cohort
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None