Purpose

This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.

Condition

Eligibility

Eligible Ages
Between 18 Years and 35 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Female - 18-35 years old - Regular menstrual cycle between 26-35 days in duration - Not using any form of hormonal contraception for at least the prior 3 months - Regular sleep patterns (7-9 hours/night) - Not taking any medications or supplements - Weight >110 lb - BMI between 18.5 and 29.5 kg/m2

Exclusion Criteria

  • Primary sleep disorder - History of shift work - Transmeridian travel in the previous 3 months - Presence of acute or chronic disease, including but not limited to: diabetes, metabolic disorders, psychiatric illness, reproductive disorders - Current pregnancy, < 6 months postpartum, and/or breastfeeding - Blood donation in the past 8 weeks - Extreme morning or evening chronotype

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Single (Participant)
Masking Description
Participants may not know to which study arm they are assigned.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Chronic variable sleep deficiency - follicular phase
This will be the first of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.
  • Behavioral: Controlled sleep
    Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.
Experimental
Chronic variable sleep deficiency - luteal phase
This will be the second of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a chronic variable sleep deficiency schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.
  • Behavioral: Controlled sleep
    Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.
Experimental
Control sleep - follicular phase
This will be the third of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the follicular phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.
  • Behavioral: Controlled sleep
    Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.
Experimental
Control sleep - luteal phase
This will be the fourth of four arms of controlled sleep manipulation. Participants randomized to this arm will be studied on a control sleep schedule during the luteal phase of their menstrual cycle. The exact sleep schedule is not provided in order to keep participants blinded to sleep conditions.
  • Behavioral: Controlled sleep
    Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment.

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Melissa A St Hilaire, Ph.D.
617-278-0620
msthilaire@rics.bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Melissa A St. Hilaire, PhD
6172780620
msthilaire@rics.bwh.harvard.edu

Detailed Description

During a 1.5-week inpatient laboratory protocol, participants will undergo one of two parallel sleep conditions during either the follicular or luteal phase of the menstrual cycle (4 study arms total). Subjects will be randomly assigned to each study arm. During their time in the laboratory, biological samples (e.g., blood) will be collected for assessment of sex steroid hormones and other analyses. Sleep quantity and quality will be monitored and responses on neurobehavioral tests and surveys will be monitored for differences across conditions.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.