Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336525
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-22
Brief Title:
Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Sleep Health in the Rural South and Its Relationships With Cardiometabolic Health Disparities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Rural communities in the southern US suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease with traditional risk factors explaining only a modest proportion of the excess burden of disease There is considerable evidence that multiple dimensions of sleep health including sleep duration efficiency timing and regularity as well as the disorders sleep apnea and insomnia affect cardiometabolic disease risk However there is currently a lack of systematically developed sleep data in rural populations The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta the RURAL Study The RURAL Sleep Study will add measures of sleep health to the complex individual social and environmental factors and health outcome measures being evaluated by the RURAL Study by incorporating minimally burdensome measures of multiple dimensions of sleep health The results are expected to inform health care providers public health officials and the general public of the prevalence risk factors and consequences of impaired sleep health in these rural communities providing a critical basis for prevention recognition and management of sleep disorders and improvement of sleep and cardiometabolic health
Detailed Description:
Rural communities in the southern US suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease with traditional risk factors explaining only a modest proportion of the excess burden of disease Growing evidence implicates poor sleep health as an important risk factor for cardiometabolic disease While this is most well established for sleep apnea and insomnia there is considerable evidence that multiple dimensions of sleep health including sleep duration efficiency timing and regularity also affect cardiometabolic disease risk Moreover rural Southern communities are likely to experience high rates of impaired sleep health reflecting high levels of psychosocial and environmental stressors such as financial stress social isolation environmental pollution and poor built environment in addition to high rates of smoking and obesity However there is currently a lack of systematically developed sleep data in rural populations
Recognizing the paucity of research on cardiometabolic risk in this high-risk rural population the NHLBI recently initiated a new longitudinal epidemiology study in rural Appalachia and Mississippi Delta the RURAL Study to identify the complex individual social and environmental factors contributing to this high burden of disease The proposed RURAL Sleep Study will complement the RURAL Study by incorporating minimally burdensome measures of multiple dimensions of sleep health at the time of baseline cohort assessment in approximately 4000 adults age 25-64 years utilizing mobile health technologies to
1 measure sleep apnea over seven consecutive nights
2 measure sleep duration timing regularity and fragmentation over multiple weeks and
3 administer standardized questionnaires to assess insomnia chronotype sleep quality sleep-related impairment and fatigue
These data will allow us to leverage the planned extensive assessments of cardiometabolic risk factors subclinical disease and psychosocial and environmental stressors and resilience factors to address the following specific aims
Aim 1a Quantify population distributions of sleep health measures in a rural cohort along dimensions of sleep apnea insomnia chronotype and sleep duration efficiency timing and regularity
Aim 1b Identify psychosocial behavioral and environmental correlates of sleep health in rural communities
Aim 2 Assess the association of sleep health with cardiometabolic risk factors and subclinical cardiovascular disease independent of other established cardiovascular and metabolic risk factors
The results are expected to inform health care providers public health officials and the general public of the prevalence risk factors and consequences of impaired sleep health in these rural communities providing a critical basis for prevention recognition and management of sleep disorders and improvement of sleep and cardiometabolic health
Recognizing the paucity of research on cardiometabolic risk in this high-risk rural population the NHLBI recently initiated a new longitudinal epidemiology study in rural Appalachia and Mississippi Delta the RURAL Study to identify the complex individual social and environmental factors contributing to this high burden of disease The proposed RURAL Sleep Study will complement the RURAL Study by incorporating minimally burdensome measures of multiple dimensions of sleep health at the time of baseline cohort assessment in approximately 4000 adults age 25-64 years utilizing mobile health technologies to
1 measure sleep apnea over seven consecutive nights
2 measure sleep duration timing regularity and fragmentation over multiple weeks and
3 administer standardized questionnaires to assess insomnia chronotype sleep quality sleep-related impairment and fatigue
These data will allow us to leverage the planned extensive assessments of cardiometabolic risk factors subclinical disease and psychosocial and environmental stressors and resilience factors to address the following specific aims
Aim 1a Quantify population distributions of sleep health measures in a rural cohort along dimensions of sleep apnea insomnia chronotype and sleep duration efficiency timing and regularity
Aim 1b Identify psychosocial behavioral and environmental correlates of sleep health in rural communities
Aim 2 Assess the association of sleep health with cardiometabolic risk factors and subclinical cardiovascular disease independent of other established cardiovascular and metabolic risk factors
The results are expected to inform health care providers public health officials and the general public of the prevalence risk factors and consequences of impaired sleep health in these rural communities providing a critical basis for prevention recognition and management of sleep disorders and improvement of sleep and cardiometabolic health
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL164462 | NIH | None | httpsreporternihgovquickSearchR01HL164462 |