Depression Clinical Trial
To determine whether objectively recorded sleep durations were mortality risk factors, whether sleep duration could be distinguished from depression as a risk factor in Women's 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.
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 Women's Health Initiative (WHI), because
insomnia increases among women at menopause, and because WHI's 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.
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