Validation and Exploration of Sleep and Mood Predictors

February 26, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

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 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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

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Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1995

Study Completion

July 1, 1999

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

July 1, 2000

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4318
  • R01HL055983 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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