Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Impact of Sleep Disruption on the Menstrual Cycle

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00456222
First received: April 2, 2007
Last updated: August 20, 2009
Last verified: August 2009
  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

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456222

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

No publications provided

Responsible Party: Elizabeth B. Klerman, MD, PhD, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00456222     History of Changes
Other Study ID Numbers: R01-HD40291, NIH R01-HD40291
Study First Received: April 2, 2007
Last Updated: August 20, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014