Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005381
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2000-05-25
Brief Title:
Prevalence of Sleep Apnea in Women
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Prevalence of Sleep Apnea in Women
Status:
COMPLETED
Status Verified Date:
2019-04
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 identify the prevalence of sleep apnea SA in women and its relationship to age to predict those women at risk for sleep apnea and to define the natural history of those with sleep apnea
Detailed Description:
BACKGROUND
Often sleep apnea is accompanied by considerable morbidity the associated excessive daytime sleepiness cardiovascular abnormalities and cognitive impairment impact greatly on daytime functioning The obese hypertensives elderly and postmenopausal women are reported to be at increased risk for sleep apnea The investigators published on the prevalence of sleep apnea in several special populations elderly subjects without sleep complaints and insomniac narcoleptic hypertensive and obese patients They established the prevalence of sleep apnea in men based on the sleep laboratory evaluation of approximately 1000 men randomly selected from a randomly generated telephone sample of 4364 men from the general population Their preliminary estimate of prevalence was that about 22 percent of the adult male population have clinically diagnosable sleep apnea Further in the male sample the age distribution was not linearly related to age Rather it peaked at approximately age 55 Finally the major risk factors appeared to be obesity and snoring The differences in the malefemale ratio in clinical and selected populations ranged from 1001 to 191 One recent study suggested that the prevalence of sleep apnea in women was about two-fold less than in men However this study did not sample the general population and used only a restricted age range 30 to 60 years which did not allow the assessment of the influence of menopause Thus the prevalence of sleep apnea in women in the general population remained largely undetermined
DESIGN NARRATIVE
In order to establish the prevalence in women with reasonable precision the prevalence study employed a two-stage sample modified from the prevalence study in men in the following two ways an expanded telephone sample N12219 women selected randomly from the general population was evaluated for clinically relevant risk factors for sleep apnea and 2 a second sample N1000 selected randomly from the first sample based on higher risk for sleep apnea including the additional risk factor of menopause was evaluated in the sleep laboratory to determine the presence of sleep apnea This strategy yielded an adequate power in order to establish the prevalence of sleep apnea requiring treatment and sleep disordered breathing in women in the general population as well as result in a large enough sample to establish the association between risk factors and sleep apnea in women In order to perform gender analyses the study compared previously published data from a total of 4364 men interviewed in an expanded telephone sample and 741men evaluated in the sleep laboratory
Often sleep apnea is accompanied by considerable morbidity the associated excessive daytime sleepiness cardiovascular abnormalities and cognitive impairment impact greatly on daytime functioning The obese hypertensives elderly and postmenopausal women are reported to be at increased risk for sleep apnea The investigators published on the prevalence of sleep apnea in several special populations elderly subjects without sleep complaints and insomniac narcoleptic hypertensive and obese patients They established the prevalence of sleep apnea in men based on the sleep laboratory evaluation of approximately 1000 men randomly selected from a randomly generated telephone sample of 4364 men from the general population Their preliminary estimate of prevalence was that about 22 percent of the adult male population have clinically diagnosable sleep apnea Further in the male sample the age distribution was not linearly related to age Rather it peaked at approximately age 55 Finally the major risk factors appeared to be obesity and snoring The differences in the malefemale ratio in clinical and selected populations ranged from 1001 to 191 One recent study suggested that the prevalence of sleep apnea in women was about two-fold less than in men However this study did not sample the general population and used only a restricted age range 30 to 60 years which did not allow the assessment of the influence of menopause Thus the prevalence of sleep apnea in women in the general population remained largely undetermined
DESIGN NARRATIVE
In order to establish the prevalence in women with reasonable precision the prevalence study employed a two-stage sample modified from the prevalence study in men in the following two ways an expanded telephone sample N12219 women selected randomly from the general population was evaluated for clinically relevant risk factors for sleep apnea and 2 a second sample N1000 selected randomly from the first sample based on higher risk for sleep apnea including the additional risk factor of menopause was evaluated in the sleep laboratory to determine the presence of sleep apnea This strategy yielded an adequate power in order to establish the prevalence of sleep apnea requiring treatment and sleep disordered breathing in women in the general population as well as result in a large enough sample to establish the association between risk factors and sleep apnea in women In order to perform gender analyses the study compared previously published data from a total of 4364 men interviewed in an expanded telephone sample and 741men evaluated in the sleep laboratory
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 |
|---|---|---|---|
| R01HL051931 | NIH | None | httpsreporternihgovquickSearchR01HL051931 |