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Impact of Sleep Disruption on the Menstrual Cycle

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00456222
Collaborator
National Institutes of Health (NIH) (NIH)
18
Enrollment
2
Locations
74
Duration (Months)
9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate whether sleep disruption affects menstrual cycle timing

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Disrupting or changing the timing or the duration of sleep

Detailed Description

Menstrual cycle dynamics were studied after sleep disruption

Study Design

Study Type:
Observational
Actual Enrollment :
18 participants
Time Perspective:
Prospective
Official Title:
Impact of Sleep Disruption on the Menstrual Cycle
Study Start Date :
Jun 1, 2003
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Aug 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy

    • Regular menstrual cycles

    Exclusion Criteria:
    • No medications affecting the menstrual cycle or sleep

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00456222
    Other Study ID Numbers:
    • R01HD040291
    • NIH R01-HD40291
    First Posted:
    Apr 4, 2007
    Last Update Posted:
    Aug 21, 2009
    Last Verified:
    Aug 1, 2009
    Keywords provided by , ,
    Sleep
    Circadian rhythms
    Menstrual cycle

    Study Results

    No Results Posted as of Aug 21, 2009