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Impact of Sleep Disruption on the Menstrual Cycle

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456222
First Posted: April 4, 2007
Last Update Posted: August 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Brigham and Women's Hospital
  Purpose
The purpose of this study is to investigate whether sleep disruption affects menstrual cycle timing

Condition Intervention
Sleep Circadian Rhythm Menstrual Cycle Behavioral: Disrupting or changing the timing or the duration of sleep

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Impact of Sleep Disruption on the Menstrual Cycle

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Biospecimen Retention:   Samples Without DNA
Blood/plasma

Enrollment: 18
Study Start Date: June 2003
Study Completion Date: August 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Luteal Behavioral: Disrupting or changing the timing or the duration of sleep
Disrupting or changing the timing or the duration of sleep
Follicular Behavioral: Disrupting or changing the timing or the duration of sleep
Disrupting or changing the timing or the duration of sleep

Detailed Description:
Menstrual cycle dynamics were studied after sleep disruption
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy women with regular menstrual cycles
Criteria

Inclusion Criteria:

  • Healthy
  • Regular menstrual cycles

Exclusion Criteria:

  • No medications affecting the menstrual cycle or sleep
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456222


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institutes of Health (NIH)
Investigators
Principal Investigator: Elizabeth B Klerman, MD PhD Brigham and Women's Hospital
Study Director: Janet E Hall, MD Massachusetts General Hospital
  More Information

Responsible Party: Elizabeth B. Klerman, MD, PhD, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00456222     History of Changes
Other Study ID Numbers: R01HD040291 ( U.S. NIH Grant/Contract )
NIH R01-HD40291
First Submitted: April 2, 2007
First Posted: April 4, 2007
Last Update Posted: August 21, 2009
Last Verified: August 2009

Keywords provided by Brigham and Women's Hospital:
Sleep
Circadian rhythms
Menstrual cycle