Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070681
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2003-10-06
Brief Title:
Outcomes of Sleep Disorders in Older Men
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-04
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:
To determine the effects of sleep disorders on cardiovascular function and disease in older men
Detailed Description:
BACKGROUND
It is estimated that over 50 percent of adults aged 65 and older report some sleep disruption while about 20 percent suffer from chronic insomnia Obstructive sleep apnea a major cause of daytime drowsiness occurs in an estimated 20-60 percent of older people depending on the definition used and the specific population being studied Despite the high prevalence of sleep disorders in the elderly there have been relatively few studies focused on the consequences Most studies have been limited by cross-sectional design small sample size or lack of comprehensive and objective assessment of sleep The study Outcomes of Sleep Disorders in Older Men will take advantage of the established cohort that has been recruited for the Osteoporotic Fractures in Men MrOS Study 5U01AR045647-Dr Eric Orwoll PI MrOS a 7-year study that began in July 1999 is a multi-center prospective study of approximately 6000 men aged 65 and older During the MrOS baseline visit a broad variety of measurements were collected including body composition and body fat distribution by dual energy X-ray absorptiometry DEXA and quantitative computed tomography bone density anthropometry performance-based tests of strength and balance medical history medication use smoking and alcohol use and other parameters Blood urine and DNA specimens have been archived for use in future studies of importance to the health of older men
DESIGN NARRATIVE
In a subcohort of 3000 MrOS participants comprehensive and accurate assessments of sleep will be added using in-home polysomnography wrist actigraphy questionnaires and other measures and prospective adjudication of cardiovascular disease CVD events to the extensive measures that have already been performed or planned in the MrOS cohort study These new measures will enable testing of several important hypotheses 1 to characterize the associations between sleep disruption and subsequent CVD events during 35 years of follow-up 2 to determine if sleep disturbances are associated with an increased risk of total and cause-specific mortality in older men 3 to test whether sleep disturbances are associated with increased risk of falls and decreased physical function 4 to test whether sleep disturbances are associated with impaired cognitive function in older men and 5 to test whether sleep disorders are associated with bone density and fracture risk in older men The bank of MrOS specimens will be supplemented to allow for testing of future hypotheses concerning the role of sleep in the development of age-related diseases and conditions
It is estimated that over 50 percent of adults aged 65 and older report some sleep disruption while about 20 percent suffer from chronic insomnia Obstructive sleep apnea a major cause of daytime drowsiness occurs in an estimated 20-60 percent of older people depending on the definition used and the specific population being studied Despite the high prevalence of sleep disorders in the elderly there have been relatively few studies focused on the consequences Most studies have been limited by cross-sectional design small sample size or lack of comprehensive and objective assessment of sleep The study Outcomes of Sleep Disorders in Older Men will take advantage of the established cohort that has been recruited for the Osteoporotic Fractures in Men MrOS Study 5U01AR045647-Dr Eric Orwoll PI MrOS a 7-year study that began in July 1999 is a multi-center prospective study of approximately 6000 men aged 65 and older During the MrOS baseline visit a broad variety of measurements were collected including body composition and body fat distribution by dual energy X-ray absorptiometry DEXA and quantitative computed tomography bone density anthropometry performance-based tests of strength and balance medical history medication use smoking and alcohol use and other parameters Blood urine and DNA specimens have been archived for use in future studies of importance to the health of older men
DESIGN NARRATIVE
In a subcohort of 3000 MrOS participants comprehensive and accurate assessments of sleep will be added using in-home polysomnography wrist actigraphy questionnaires and other measures and prospective adjudication of cardiovascular disease CVD events to the extensive measures that have already been performed or planned in the MrOS cohort study These new measures will enable testing of several important hypotheses 1 to characterize the associations between sleep disruption and subsequent CVD events during 35 years of follow-up 2 to determine if sleep disturbances are associated with an increased risk of total and cause-specific mortality in older men 3 to test whether sleep disturbances are associated with increased risk of falls and decreased physical function 4 to test whether sleep disturbances are associated with impaired cognitive function in older men and 5 to test whether sleep disorders are associated with bone density and fracture risk in older men The bank of MrOS specimens will be supplemented to allow for testing of future hypotheses concerning the role of sleep in the development of age-related diseases and conditions
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070848 | NIH | None | httpsreporternihgovquickSearchR01HL070848 |