Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059111
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2003-04-17
Brief Title:
Mechanisms Mediating Cardiovascular Disease in Children With Obstructive Sleep Apnea
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-05
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 identify the early effects of obstructive sleep apnea on the cardiovascular system of children
Detailed Description:
BACKGROUND
Obstructive sleep apnea OSA is an important clinical disorder occurring in men women and children with a prevalence of 4 percent 2 percent and 1-3 percent respectively OSA is under active study in adults and is definitely linked with increased cardiovascular morbidity even in its mild to moderate clinical forms In contrast OSA has not been well studied in children and the potential deleterious consequences on cardiovascular function have received little or no attention
DESIGN NARRATIVE
The study will examine in children 1 The interaction between OSA and baroreflex dysfunction 2 The relation of OSA severity and baroreflex dysfunction to abnormalities in blood pressure control during wakefulness and sleep 3 The association of the diminished baroreflex gain and impaired blood pressure control with an index of end organ damage the left ventricular mass index and 4 Whether effective treatment of OSA results in significant improvement in baroreceptor function blood pressure control and a decrease in left ventricular mass index A cross-sectional study will be conducted in 8-12 year old children with OSA and a matched group of normal children Studies include baroreceptor function 24-hour ambulatory blood pressure and left ventricular mass index Baroreceptor function will be measured by non-invasive techniques based on combined computer analysis of heart rate and blood pressure measured by portapres 24-hour ambulatory blood pressure will be measured by a Spacelab monitor and left ventricular mass index will be measured by direct M-mode echocardiogram A longitudinal study will be conducted on the effect of adequate treatment of OSA on baroreceptor function daytime and nocturnal blood pressure and left ventricular mass index A cohort of children with OSA and a matched group of normal controls will be followed for a period of 12 months after treatment of the disorder Results are expected to show that children with OSA have decreased baroreceptor sensitivity elevated nocturnal blood pressure and increased left ventricular mass index and that effective therapy for OSA as determined by polysomnography will improve or normalize baroreceptor sensitivity as well as nocturnal blood pressures and will lead to a decrease in left ventricular mass index
Obstructive sleep apnea OSA is an important clinical disorder occurring in men women and children with a prevalence of 4 percent 2 percent and 1-3 percent respectively OSA is under active study in adults and is definitely linked with increased cardiovascular morbidity even in its mild to moderate clinical forms In contrast OSA has not been well studied in children and the potential deleterious consequences on cardiovascular function have received little or no attention
DESIGN NARRATIVE
The study will examine in children 1 The interaction between OSA and baroreflex dysfunction 2 The relation of OSA severity and baroreflex dysfunction to abnormalities in blood pressure control during wakefulness and sleep 3 The association of the diminished baroreflex gain and impaired blood pressure control with an index of end organ damage the left ventricular mass index and 4 Whether effective treatment of OSA results in significant improvement in baroreceptor function blood pressure control and a decrease in left ventricular mass index A cross-sectional study will be conducted in 8-12 year old children with OSA and a matched group of normal children Studies include baroreceptor function 24-hour ambulatory blood pressure and left ventricular mass index Baroreceptor function will be measured by non-invasive techniques based on combined computer analysis of heart rate and blood pressure measured by portapres 24-hour ambulatory blood pressure will be measured by a Spacelab monitor and left ventricular mass index will be measured by direct M-mode echocardiogram A longitudinal study will be conducted on the effect of adequate treatment of OSA on baroreceptor function daytime and nocturnal blood pressure and left ventricular mass index A cohort of children with OSA and a matched group of normal controls will be followed for a period of 12 months after treatment of the disorder Results are expected to show that children with OSA have decreased baroreceptor sensitivity elevated nocturnal blood pressure and increased left ventricular mass index and that effective therapy for OSA as determined by polysomnography will improve or normalize baroreceptor sensitivity as well as nocturnal blood pressures and will lead to a decrease in left ventricular mass index
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 |
|---|---|---|---|
| R01HL070907-01A1 | NIH | None | httpsreporternihgovquickSearchR01HL070907-01A1 |