Cardiovascular DiseasesNCT06294964
Intervention and Effect of Sleep Pattern on Cardio-cerebrovascular Disease
A study testing sleep education, behavioral education in people with Cardiovascular Diseases and Non-Communicable Chronic Diseases, run by RenJi Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Non-Communicable Chronic Diseases
- What is being tested?
- sleep education, behavioral education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,800 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- sleep education, behavioral education
- Keywords
- sleep intervention; sleep education; cardio-cerebrovascular diseases
- Medical subject headings
- Cardiovascular Diseases, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep education, behavioral educationBehavioural
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?
| Study group | Role | What they receive |
|---|---|---|
| sleep education group | Experimental | Not described Receives: Behavioral: sleep education, behavioral education |
| routine management group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
all cause death
all cause death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Pu, MD, PhD, Principal investigator, Cardiology, Ren Ji Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294964
- Sponsor's protocol ID
- Sleep Education
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Education and Its Effects on Cardio-cerebrovascular Disease in Pudong Community Elderly Cohort
- ClinicalTrials.gov ID
- NCT06294964
- Acronym / sponsor ID
- Sleep Education
- Keywords
- sleep intervention; sleep education; cardio-cerebrovascular diseases
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12,800 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleep education group | Experimental | Behavioral: sleep education, behavioral education |
| routine management group | No intervention | – |
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep education, behavioral educationProvide 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? | Behavioural | sleep education group |
Primary outcome
the incidence and/or prevalence of cardiovascular diseases such as myocardial infarction, stroke, heart failure, and cardiovascular death
Time frame: 3 years
the incidence and/or prevalence of cardiovascular diseases such as myocardial infarction, stroke, heart failure, and cardiovascular death
1 secondary outcome
all cause death
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Pu, MD, PhD principal investigator
Cardiology, Ren Ji Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep education, behavioral education in people with Cardiovascular Diseases and Non-Communicable Chronic Diseases, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence and/or prevalence of cardiovascular diseases such as myocardial infarction, stroke, heart failure, and cardiovascular death (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.