Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005401
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Validation and Exploration of Sleep and Mood Predictors
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:
2000-07
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 whether objectively recorded sleep durations were mortality risk factors whether sleep duration could be distinguished from depression as a risk factor in Womens Health Initiative WHI data and whether sleep-associated risks were attributable to specific pathophysiologic processes such as sleep apnea circadian rhythm phase advances or deficiencies of melatonin or deficiencies of reproductive steroids The study was ancillary to the WHI
Detailed Description:
BACKGROUND
Both reported short sleep and reported long sleep are major predictors of excess mortality risk but the importance of reported sleep duration as a risk factor is not yet known Sleep-related risks are of special interest to The Womens Health Initiative WHI because insomnia increases among women at menopause and because WHIs hormone replacement therapy HRT and dietary modification DM may influence sleep The WHI is an exciting opportunity to examine whether risks associated with reported sleep durations can be explained by a selection of intercurrent conditions but the broad WHI design does not control for important potential confounders Explicitly the broad WHI design by itself cannot determine if behaviorally-modifiable objective sleep durations are the primary risk factor
DESIGN NARRATIVE
This ancillary project supplemented the WHI Observational Study OS by performing additional examinations on 600 San Diego OS women These volunteers underwent home sleep recordings hormone measurement and detailed psychiatric interviews To facilitate distinction of affective and sleep factors in WHI outcomes the types and severity of depression in the OS subsample and the validity and reliability of sleep items in questionnaires given to WHI women were examined
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Both reported short sleep and reported long sleep are major predictors of excess mortality risk but the importance of reported sleep duration as a risk factor is not yet known Sleep-related risks are of special interest to The Womens Health Initiative WHI because insomnia increases among women at menopause and because WHIs hormone replacement therapy HRT and dietary modification DM may influence sleep The WHI is an exciting opportunity to examine whether risks associated with reported sleep durations can be explained by a selection of intercurrent conditions but the broad WHI design does not control for important potential confounders Explicitly the broad WHI design by itself cannot determine if behaviorally-modifiable objective sleep durations are the primary risk factor
DESIGN NARRATIVE
This ancillary project supplemented the WHI Observational Study OS by performing additional examinations on 600 San Diego OS women These volunteers underwent home sleep recordings hormone measurement and detailed psychiatric interviews To facilitate distinction of affective and sleep factors in WHI outcomes the types and severity of depression in the OS subsample and the validity and reliability of sleep items in questionnaires given to WHI women were examined
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 |
|---|---|---|---|
| R01HL055983 | NIH | None | httpsreporternihgovquickSearchR01HL055983 |