Validation and Exploration of Sleep and Mood Predictors
NCT ID: NCT00005401
Last Updated: 2016-02-29
Study Results
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Basic Information
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COMPLETED
OBSERVATIONAL
1995-08-31
1999-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Eligibility Criteria
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Inclusion Criteria
100 Years
MALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
References
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Kripke DF, Elliot JA, Youngstedt SD, Smith JS. Melatonin: marvel or marker? Ann Med. 1998 Feb;30(1):81-7. doi: 10.3109/07853899808999388.
Kripke DF, Klauber MR, Wingard DL, Fell RL, Assmus JD, Garfinkel L. Mortality hazard associated with prescription hypnotics. Biol Psychiatry. 1998 May 1;43(9):687-93. doi: 10.1016/s0006-3223(97)00292-8.
Kripke DF. Light treatment for nonseasonal depression: speed, efficacy, and combined treatment. J Affect Disord. 1998 May;49(2):109-17. doi: 10.1016/s0165-0327(98)00005-6.
Jean-Louis G, Kripke DF, Assmus JD, Langer RD. Sleep-wake patterns among postmenopausal women: a 24-hour unattended polysomnographic study. J Gerontol A Biol Sci Med Sci. 2000 Mar;55(3):M120-3. doi: 10.1093/gerona/55.3.m120.
Jean-Louis G, Kripke DF, Ancoli-Israel S, Klauber MR, Sepulveda RS, Mowen MA, Assmus JD, Langer RD. Circadian sleep, illumination, and activity patterns in women: influences of aging and time reference. Physiol Behav. 2000 Jan;68(3):347-52. doi: 10.1016/s0031-9384(99)00186-9.
Jean-Louis G, von Gizycki H, Zizi F. Predictors of subjective sleepiness induced by melatonin administration. J Psychosom Res. 1999 Oct;47(4):355-8. doi: 10.1016/s0022-3999(98)00076-2.
Jean-Louis G, Mendlowicz MV, Von Gizycki H, Zizi F, Nunes J. Assessment of physical activity and sleep by actigraphy: examination of gender differences. J Womens Health Gend Based Med. 1999 Oct;8(8):1113-7. doi: 10.1089/jwh.1.1999.8.1113.
Lasko TA, Kripke DF, Elliot JA. Melatonin suppression by illumination of upper and lower visual fields. J Biol Rhythms. 1999 Apr;14(2):122-5. doi: 10.1177/074873099129000506.
Jean-Louis G, Zizi F, von Gizycki H, Hauri P. Actigraphic assessment of sleep in insomnia: application of the Actigraph Data Analysis Software (ADAS). Physiol Behav. 1999 Jan 1-15;65(4-5):659-63. doi: 10.1016/s0031-9384(98)00213-3.
Other Identifiers
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4318
Identifier Type: -
Identifier Source: org_study_id
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